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Business Wire
07-05-2025
- Health
- Business Wire
Gilead to Present Latest Advancements Across Primary Biliary Cholangitis and Viral Hepatitis
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD) today announced new research to be presented at the European Association for the Study of the Liver (EASL) Congress, May 7-10, 2025, Amsterdam, furthering Gilead's commitment to transform the lives of people living with liver disease. New data to be presented at EASL will include a subgroup analysis from ASSURE, an ongoing open-label study, and an analysis of the Phase 3 RESPONSE trial and the open-label extension. Data will reinforce the effectiveness of Livdelzi ® (seladelpar), known as Lyvdelzi ® in the European Union, in reducing pruritus (chronic itch), a debilitating common symptom of primary biliary cholangitis (PBC). Moreover, the results will highlight seladelpar's ability to deliver a sustained biochemical response regardless of prior treatment history, and as an option for a broad range of people with PBC. 'Our focus remains on addressing the areas of greatest unmet need across liver diseases,' said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. 'Our deep expertise in treating liver disease has delivered the first and only treatment for hepatitis delta and the first treatment for primary biliary cholangitis that has demonstrated statistically significant improvements across both chronic itch and markers of disease progression. Our studies continue to deliver transformational insights and therapies to help foster healthier futures for the millions of people who live with viral hepatitis and those who live with less prevalent liver conditions with remaining high unmet needs.' Key findings from 29 accepted abstracts will include two oral presentations showcasing new data on the critical goal of maintained virologic response following treatment with 2 mg and 10 mg bulevirtide in people living with hepatitis delta virus (HDV). These findings build on the wealth of long-term data for the treatment of chronic HDV. A late breaker presentation on the final results from the pivotal MYR301 Phase 3 study evaluating the efficacy and safety of 2 mg and 10 mg bulevirtide as monotherapy will reveal long-term response rates, including the proportion of participants with undetectable virus levels two years after treatment cessation. In hepatitis B (HBV), Gilead will present initial results from a Phase 1a study of a novel investigational therapeutic vaccine that shows early promise towards the goal of achieving a functional cure for HBV infection. A separate analysis of real-world data showed that individuals with low-level HBV viremia still have a risk of negative events. Additionally, a retrospective analysis of participants enrolled in two Phase 3 studies evaluating Vemlidy ® (tenofovir alafenamide) using a risk score for liver cancer highlights the importance of treatment to help reduce liver cancer risk. Gilead will also showcase real-world data on hepatitis C (HCV), demonstrating the effects of direct-acting antivirals (DAA) against all genotypes of the virus across diverse geographical regions, supporting the global applicability of HCV treatment guidelines. In addition, new real-world insights will show that the choice of DAA for people living with HCV taking other medicines, such as antipsychotics, was associated with reducing the problem of drug-drug interactions. To help raise awareness about HCV and encourage people to get screened for the disease, Gilead will again support EASL's 'Love Your Liver' Campaign at the congress. At the EASL Congress, Gilead, in collaboration with the PBC Foundation and Friends of the PBC Foundation, will also launch 'All the Feelings with PBC,' a campaign highlighting the experiences of people living with PBC and emphasizing the importance of listening to and addressing their needs in clinical practice and research. The campaign will feature paintings by Berlin-based artist, Nour Khwies, based on the physical and emotional experiences of people living with PBC: Dilek from Germany, Angela from Scotland, Joana from Portugal, and L. Marie from the United States, whose painting will be painted live at EASL. For more information on the EASL Congress 2025 and Gilead's presentations, please visit the congress website. For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. The company has helped to transform hepatitis C from a chronic condition into a curable condition. For individuals living with hepatitis B or hepatitis delta, Gilead's focus on advancing medicines drives hope that today's research will turn into tomorrow's cures. Beyond viral hepatitis, Gilead is working to deliver advanced treatments for people living with PBC. The commitment of Gilead does not stop there. Through ground-breaking science and collaborative partnerships, the company strives to create healthier futures for everyone living with liver disease. Gilead remains devoted to a future without liver disease. Marketing Authorization In July 2023, the European Commission (EC) granted full Marketing Authorization (MA) for Hepcludex ® (bulevirtide) 2 mg for the treatment of adults with chronic HDV and compensated liver disease. Bulevirtide was initially granted a conditional MA from the EC in July 2020 to provide people living with HDV urgent access to treatment. Bulevirtide's conditional MA license in the UK was converted to a full MA in August 2023, and a full MA was granted in Switzerland in February 2024. In regions where bulevirtide is not approved, including the U.S., bulevirtide 2 mg is an investigational product. In these regions, health authorities have not established the safety and efficacy of bulevirtide. Bulevirtide 10 mg is an investigational product and is not approved anywhere globally. In February 2025, the European Commission (EC) granted conditional marketing authorization for Lyvdelzi ® (seladelpar) for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. Lyvdelzi provides an important treatment option for people living with PBC in the European Economic Area (EEA). Gilead is working with health authorities across Europe to ensure people living with PBC who are eligible for Lyvdelzi have access as soon as possible. Continued approval of Lyvdelzi for the approved indication will be contingent on verification and description of clinical benefit in confirmatory trial(s). Lyvdelzi has Priority Medicine (PRIME) designation in the EU, assigned to optimize the development of novel medicines that target conditions with an unmet medical need for which no treatment options exist or where they can offer a major therapeutic advantage over existing treatments, as well as well as Orphan Drug Designation for the treatment of people living with PBC. Livdelzi ® received conditional approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in January 2025. In the U.S., Livdelzi ® obtained accelerated approval for the treatment of PBC by the U.S. Food and Drug Administration (FDA) in August 2024. Livdelzi received Breakthrough Therapy Designation, as well as Orphan Drug Designation for the treatment of people living with PBC. As part of the FDA accelerated approval, Gilead has committed to AFFIRM, a long-term outcomes study, which has begun in people with compensated cirrhosis. Continued U.S. approval may be contingent upon verification of clinical benefit in confirmatory trial(s). Regulatory review for Livdelzi is underway in Canada, Australia, and Switzerland. U.S. Indication for Livdelzi® Livdelzi is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA approved this indication under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use: Use of Livdelzi is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). U.S. Important Safety Information for Livdelzi Warnings and Precautions Fractures: Fractures occurred in 4% of Livdelzi-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with Livdelzi and monitor bone health according to current standards of care. Liver Test Abnormalities: Livdelzi has been associated with dose-related increases in serum transaminase (AST and ALT) levels > 3 x ULN in patients receiving 50 mg and 200 mg once daily (5x and 20x higher than the recommended dosage of 10 mg once daily). Perform baseline clinical and laboratory testing when starting Livdelzi® and monitor thereafter according to routine patient management. Interrupt treatment if the liver tests (ALT, AST, total bilirubin, and/or ALP) worsen, or if the patient develops signs and symptoms of clinical hepatitis (eg, jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting Livdelzi. Biliary Obstruction: Avoid use of Livdelzi in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt Livdelzi and treat as clinically indicated. Adverse Reactions The most common adverse reactions (≥5%) with Livdelzi were headache (8%), abdominal pain (7%), nausea (6%), abdominal distension (6%), and dizziness (5%). Drug Interactions OAT3 Inhibitors and Strong CYP2C9 Inhibitors: Avoid co-administration with L due to increased Livdelzi exposure. Rifampin: Monitor biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during Livdelzi treatment. Coadministration may result in delayed or suboptimal biochemical response of Livdelzi. Dual Moderate CYP2C9 and Moderate-to-Strong CYP3A4 Inhibitors and BCRP Inhibitors (e.g., cyclosporine): Monitor closely for adverse effects. Concomitant administration with Livdelzi may increase Livdelzi exposure. CYP2C9 Poor Metabolizers Using Moderate-to-Strong CYP3A4 Inhibitors: Monitor more frequently for adverse reactions as concomitant use of a moderate-to-strong CYP3A4 inhibitor in patients who are CYP2C9 poor metabolizers may increase Livdelzi exposure and risk of LIVDELZI adverse reactions. Bile Acid Sequestrants: Administer Livdelzi at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible. Pregnancy and Lactation Pregnancy: There is insufficient data from human pregnancies exposed to Livdelzi to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Gilead Sciences, Inc., at 1-800-445-3235. Lactation: There is no data on the presence of Livdelzi in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Livdelzi and any potential adverse effects on the breastfed infant from Livdelzi. U.S. Indication for Vemlidy ® VEMLIDY is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease. U.S. Important Safety Information for and Indication for the Use of Vemlidy BOXED WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted. Warnings and Precautions Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients: Due to this risk, VEMLIDY alone should not be used for the treatment of HIV-1 infection. Safety and efficacy of VEMLIDY have not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used. New Onset or Worsening Renal Impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome, have been reported with TAF-containing products. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients – See Dosage and Administration. Lactic Acidosis and Severe Hepatomegaly with Steatosis: Fatal cases have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (TDF). Discontinue VEMLIDY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. Adverse Reactions Most common adverse events in the week 96 pediatric population reported in ≥5% were: nasopharyngitis, headache, COVID-19, pyrexia, diarrhea, upper respiratory tract infection, cough, respiratory tract infection viral, abdominal pain upper. Overall, abdominal pain upper and metabolic nephropathy were the only study drug–related adverse events, which occurred in > 1 participant, reported in 2.3% (2/88 participants) each. Drug Interactions Coadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions. Coadministration of VEMLIDY is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John's wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY. Drugs that strongly affect P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) activity may lead to changes in VEMLIDY absorption. Coadministration of VEMLIDY with carbamazepine, the tenofovir alafenamide dose should be increased to two tablets once daily. Consult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments. Dosage and Administration Testing Prior to Initiation: HIV infection. Prior to or When Initiating, and During Treatment: On a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Dosage: 1 tablet taken once daily with food. Renal Impairment: Not recommended in patients with end-stage renal disease (ESRD; eCrCl <15 mL/min) who are not receiving chronic hemodialysis; in patients on chronic hemodialysis, on hemodialysis days, administer VEMLIDY after completion of hemodialysis treatment. No data are available to make dose recommendations in pediatric patients with renal impairment. Hepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Lyvdelzi®/Livdelzi® (seladelpar), Vemlidy ®, bulevirtide, sofosbuvir, velpatasvir, GS-2829 and GS-6779 (such as the ASSURE, MYR301, RESPONSE, SVR10K and any confirmatory studies); uncertainties relating to regulatory applications and related filing and approval timelines, including additional pending and potential applications for seladelpar; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; uncertainties regarding Gilead's ability to coordinate access to seladelpar in a timely manner or at all; the risk that physicians may not see the benefits of prescribing seladelpar for treatment of PBC; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Hepcludex, Lyvdelzi, Livdelzi, Vemlidy, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. Full Prescribing Information for Livdelzi® and Vemlidy® are available at
Business Wire
07-05-2025
- Health
- Business Wire
Gilead's Livdelzi ® (Seladelpar) Demonstrated Consistent Efficacy and Safety Regardless of Prior Treatment History in New Data Presented at EASL 2025
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from multiple analyses which reinforce that Livdelzi ® (seladelpar), known as Lyvdelzi ® in the European Union, is effective and generally well-tolerated for the treatment of primary biliary cholangitis (PBC) and also provides sustained biochemical response in adults with PBC regardless of prior treatment history. Another analysis provides evidence supporting that Livdelzi delivered clinically and statistically significant improvements in pruritus. These data and more were presented at the European Association for the Study of the Liver (EASL) Congress 2025 in Amsterdam, Netherlands, from May 7–10. Livdelzi Efficacy in Participants with Prior Fibrate or Obeticholic Acid Use An interim analysis from ASSURE (NCT03301506), an ongoing, open-label, long-term study, reinforces the efficacy and safety profile of Livdelzi in people with PBC, including those with prior fibrate or obeticholic acid use. This analysis assesses participants from the pivotal Phase 3 placebo-controlled RESPONSE (NCT04620733) study and after participant rollover into the open-label ASSURE study, with or without prior fibrate or obeticholic acid use. Among those with 18 months of exposure to Livdelzi, including 12 months in RESPONSE and 6 months in ASSURE, 60% (9/15) of participants with prior fibrate or obeticholic acid use achieved the composite biochemical response, as compared to 62% (54/87) of those without prior fibrate or obeticholic acid use. Among participants who started Livdelzi in ASSURE after previously receiving placebo in RESPONSE, 64% (7/11) of participants with prior fibrate or obeticholic acid use, as compared to 78% (32/41) of participants without prior fibrate or obeticholic acid use achieved the composite biochemical response after 6 months of receiving Livdelzi (Month 6 of ASSURE). Safety was similar regardless of prior fibrate or obeticholic acid use. No treatment-related serious adverse events (SAEs) were reported. 'Building on the momentum of Livdelzi's launch, these new data presented at EASL further reinforce its potential as a meaningful treatment option for people living with PBC,' said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. 'We are particularly encouraged by the sustained biochemical response seen with Livdelzi, even among those who previously received fibrates or obeticholic acid. These results strengthen the evidence supporting Livdelzi's efficacy and tolerability across a broad population of patients, including those seeking alternatives to current therapies. We remain focused on addressing significant unmet needs and driving progress in liver health.' Livdelzi and Meaningful Change in Pruritus Up to 80% of people with PBC experience symptoms such as pruritus (chronic itch) and fatigue, both of which can profoundly compromise quality of life. The Pruritus Numeric Rating Scale (NRS) can evaluate treatment effects to see if a therapy is working, as well as examine the meaningful within-person change (MWPC) in the Pruritus NRS that people with PBC with pruritus perceive as a beneficial treatment effect. Using anchor-based analyses, a new study of the qualitative data from the participants of the RESPONSE trial with moderate-to-severe pruritus (NRS ≥ 4) at baseline (n=72) provides evidence supporting that Livdelzi delivered clinically and statistically significant improvements in pruritus. Results demonstrated that MWPC estimates of ≥ 3-points on the Pruritus NRS corresponded to 'moderate improvement' as validated by PGI-C and 1-category improvement for PGI-S anchors. The data overall, including half of those interviewed (n=6/12), suggest a 3-point improvement in Pruritus NRS, as seen with seladelpar in the RESPONSE study, is a meaningful change. These findings highlight the potential of Livdelzi to address this debilitating symptom. NRS scores were measured against two anchor analyses, the 7-day recall Patient Global Impression of Severity of pruritus (PGI-S) and the Patient Global Impression of Change of pruritus (PGI-C), which were administered at study visits. The MWPC threshold estimates were validated using distribution-based methods and empirical cumulative distribution function (eCDF) curves. Additionally, previously collected qualitative interviews were used to evaluate meaningful change on the Pruritus NRS in people with PBC with pruritus (NRS≥ 4) outside of the trial. 'Seladelpar is uniquely positioned as the only once-daily oral treatment that has statistically significant outcomes for both the underlying disease and the burdensome symptom of pruritus in people with PBC,' said Alejandra Maria Villamil, MD, Chief of Autoimmune Liver Diseases Unit Hospital Italiano de Buenos Aires Buenos Aires, Argentina. 'The demonstrated improvement in pruritus, combined with its established safety and efficacy profile, reinforces seladelpar as an on-label treatment option for people with PBC.' Expanding Global Access for the Treatment of PBC in EEA Recently, the European Commission (EC) granted conditional marketing authorization for Lyvdelzi (seladelpar) for the treatment of PBC in combination with UDCA in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. Lyvdelzi (an orphan designated product) provides an important treatment option for people living with the rare liver disease in the European Economic Area (EEA). Gilead is working with health authorities across Europe to ensure people living with PBC who are eligible for seladelpar have access as soon as possible. Lyvdelzi has been granted conditional marketing authorization in the EU. Continued approval of Lyvdelzi for the approved indication may be contingent on verification and description of clinical benefit in confirmatory trial(s). Outside of the EEA, Livdelzi was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2024 and conditional approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in January 2025. Regulatory review for Livdelzi is also underway in Canada and Australia. For more information on the EASL Congress 2025 and Gilead's presentations, please visit the congress website. About ASSURE (NCT03301506) ASSURE is an open-label, long-term study to evaluate the safety and tolerability of Livdelzi in people with primary biliary cholangitis (PBC). who have already participated in other PBC clinical trials of Livdelzi. The ASSURE study includes participants from previous studies of Livdelzi in PBC, including the Phase 3 registrational RESPONSE study and legacy clinical trials. Legacy studies include the open label Phase 2 dose-ranging study (2 mg, 5 mg, or 10 mg Livdelzi), the open label Phase 3/4 long-term safety study (5 mg or 10 mg Livdelzi), the Phase 3 placebo-controlled ENHANCE study (5 mg or 10 mg Livdelzi vs placebo), and the ongoing open label study in people with PBC and hepatic impairment. About RESPONSE (NCT04620733) RESPONSE was a pivotal Phase 3, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of Livdelzi in adults with primary biliary cholangitis (PBC) who have shown inadequate response or intolerance to ursodeoxycholic acid (UDCA). The trial enrolled 193 participants across multiple sites worldwide. RESPONSE assessed the key biomarker of cholestasis alkaline phosphatase (ALP) and other parameters of liver function, as well as secondary endpoints including pruritus and other patient quality of life measurements. Participants in the RESPONSE trial received a daily oral dose of 10 mg of Livdelzi for 12 months. The trial aimed to address the high unmet need for effective second-line therapies for individuals with PBC. The approvals of Livdelzi were based primarily on data from the RESPONSE study. About ENHANCE (NCT03602560) ENHANCE was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of seladelpar in participants with primary biliary cholangitis (PBC) and an inadequate response or intolerance to UDCA. The trial investigated the potential of seladelpar to improve biochemical markers of liver function and reduce pruritus, and assessed safety. The ENHANCE study was terminated early due to reasons determined to be unrelated to Livdelzi. About PBC PBC is a chronic, autoimmune disease of the bile ducts that affects approximately 130,000 Americans. PBC is more common in women and causes liver damage that can progress to liver failure and result in the need for liver transplant, if left untreated. The most common symptoms of PBC are pruritus (chronic itch) and fatigue, which up to 80% of people with PBC can experience and can profoundly compromise quality of life. Symptoms of PBC are often invisible to others and the journey to a PBC diagnosis can be long and challenging. There is currently no cure for PBC, and treatment goals include slowing disease progression and reducing the symptoms related to cholestasis (impaired bile flow), such as cholestatic itch. The effect is primarily measured by an improvement in liver biochemical tests, including the normalization of alkaline phosphatase (ALP) levels, an important marker of disease progression in PBC. About Livdelzi Livdelzi is an oral PPAR-delta agonist, or delpar, for the treatment of PBC. PPAR-delta has been shown to regulate critical metabolic and liver disease pathways. Preclinical and clinical data indicate Livdelzi has anticholestatic, anti-inflammatory, antipruritic, and antifibrotic effects. Livdelzi has potential to help meet the current unmet need of people living with PBC, as the first and only treatment that achieved statistically significant improvements across biochemical response, ALP normalization, and pruritus versus placebo. Pruritus is a common symptom that can significantly impair quality of life in people with PBC. U.S. Indication for Livdelzi Livdelzi is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction of ALP. Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use: Use of Livdelzi is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). U.S. Important Safety Information for Livdelzi Warnings and Precautions Fractures: Fractures occurred in 4% of LIVDELZI-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with LIVDELZI and monitor bone health according to current standards of care. Liver Test Abnormalities: LIVDELZI has been associated with dose-related increases in serum transaminase (AST and ALT) levels > 3 x ULN in patients receiving 50 mg and 200 mg once daily (5x and 20x higher than the recommended dosage of 10 mg once daily). Perform baseline clinical and laboratory testing when starting LIVDELZI and monitor thereafter according to routine patient management. Interrupt treatment if the liver tests (ALT, AST, total bilirubin, and/or ALP) worsen, or if the patient develops signs and symptoms of clinical hepatitis (eg, jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting LIVDELZI. Biliary Obstruction: Avoid use of LIVDELZI in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt LIVDELZI and treat as clinically indicated. Adverse Reactions The most common adverse reactions (≥5%) with LIVDELZI were headache (8%), abdominal pain (7%), nausea (6%), abdominal distension (6%), and dizziness (5%). Drug Interactions OAT3 Inhibitors and Strong CYP2C9 Inhibitors: Avoid coadministration with LIVDELZI due to increased LIVDELZI exposure. Rifampin: Monitor biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during LIVDELZI treatment. Coadministration may result in delayed or suboptimal biochemical response of LIVDELZI. Dual Moderate CYP2C9 and Moderate-to-Strong CYP3A4 Inhibitors and BCRP Inhibitors (e.g., cyclosporine): Monitor closely for adverse effects. Concomitant administration with LIVDELZI may increase LIVDELZI exposure. CYP2C9 Poor Metabolizers Using Moderate-to-Strong CYP3A4 Inhibitors: Monitor more frequently for adverse reactions as concomitant use of a moderate-to-strong CYP3A4 inhibitor in patients who are CYP2C9 poor metabolizers may increase LIVDELZI exposure and risk of LIVDELZI adverse reactions. Bile Acid Sequestrants: Administer LIVDELZI at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible. Pregnancy and Lactation Pregnancy: There are insufficient data from human pregnancies exposed to LIVDELZI to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Gilead Sciences, Inc., at 1-800-445-3235. Lactation: There are no data on the presence of LIVDELZI in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LIVDELZI and any potential adverse effects on the breastfed infant from LIVDELZI. About Gilead Sciences in Liver Disease For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. The company has helped to transform hepatitis C from a chronic condition into one that can be cured for millions of people. For individuals living with hepatitis B or D, Gilead's focus on advancing medicines drives hope that today's research will turn into tomorrow's cures. Beyond viral hepatitis, Gilead is working to deliver advanced treatments for people living with PBC. The commitment of Gilead doesn't stop there. Through ground-breaking science and collaborative partnerships, the company strives to create healthier futures for everyone living with liver disease. Gilead remains devoted to a future without liver disease. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving seladelpar (such as the ASSURE, ENHANCE, RESPONSE and any confirmatory studies); uncertainties relating to regulatory applications and related filing and approval timelines, including additional pending and potential applications for seladelpar; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; uncertainties regarding Gilead's ability to coordinate access to seladelpar in a timely manner or at all; the risk that physicians may not see the benefits of prescribing seladelpar for treatment of PBC; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Livdelzi, Lyvdelzi, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
Yahoo
23-04-2025
- Business
- Yahoo
Kestra Medical Technologies to Showcase Innovation in Sudden Cardiac Arrest Protection and Recovery at Heart Rhythm 2025
Company to spotlight ASSURE WCD performance and expanded clinical applications KIRKLAND, Wash., April 23, 2025 (GLOBE NEWSWIRE) -- Kestra Medical Technologies, Ltd. (Nasdaq: KMTS) ('Kestra'), a wearable medical device and digital healthcare company, announced today it will exhibit at Heart Rhythm 2025, the annual meeting of the Heart Rhythm Society (HRS), taking place April 24-27 at the San Diego Convention Center. This marks Kestra's first major industry showcase following its successful IPO earlier this year. Kestra will debut an immersive in-booth experience designed to bring the ASSURE® system to life—demonstrating how this innovative technology is redefining protection for patients at risk of sudden cardiac arrest. By combining lifesaving defibrillation therapy with intuitive, intelligent, and connected diagnostic and patient support capabilities, the ASSURE system is a key part of a broader vision for a holistic cardiac care ecosystem that supports patients and providers across the recovery journey. 'Our presence at Heart Rhythm 2025 comes at a pivotal time for Kestra,' said Brian Webster, President and Chief Executive Officer of Kestra. 'Following our IPO, we're moving forward with increasing momentum—and this year's HRS meeting is an opportunity to demonstrate how the ASSURE system goes beyond protection to offer a smarter, more connected recovery experience for both patients and care teams.' In addition to exhibiting, Kestra will also present new real-world clinical data highlighting the impact of the ASSURE system. Kestra is also proud to sponsor the Women in EP Luncheon for the fourth consecutive year—underscoring its ongoing commitment to leadership, innovation, and equity in cardiovascular care. About KestraKestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, please visit Media contactRhiannon Investor contactNeil in to access your portfolio
Yahoo
16-04-2025
- Politics
- Yahoo
FAA Testing Drone Detection Systems In New Jersey
The FAA released videos on Tuesday showcasing its latest effort to test drone-detecting technologies that is now underway in New Jersey. The agency told us the tests are not related to the massive wave of reported drone incursions over the state last year, as well as sensitive military installations in the U.S. and U.K., but the results could help improve situational awareness of unmanned aircraft in the skies. However, Transportation Secretary Sean Duffy intimated that these tests are a direct result of the Jersey drone incursions in a video just posted on X. Do you remember the drone fiasco in New Jersey last year? Do you remember when President Biden's administration refused to tell the American people who was flying the drones? It scared the crap out of people. It was wrong. President Trump and I believe in radical transparency.… — Secretary Sean Duffy (@SecDuffy) April 15, 2025 The tests, which began Monday and are expected to last until April 25, are taking place over the water and near the Cape May Ferry Terminal during the daytime on weekdays only, according to the agency. They are being conducted by the FAA's Center of Excellence for UAS Research (ASSURE). The Delaware River Bay Authority Police and other local first responders will also participate. The videos offer a small glimpse into this testing process. One video shows the detection and tracking systems being tested and several drones of different sizes on the ground and in flight. The other video shows smaller drones being flown. The FAA 'has been testing drone detection technologies at airports over the last few years and is expanding testing to off-airport locations,' the spokesman told The War Zone in response to our question about what sparked this effort. 'These tests will help determine the effectiveness of these technologies and whether they might interfere with FAA or aircraft navigation systems.' More than 100 drone sightings near airports are reported to the FAA each month, 'and we want to send a clear message that operating drones around airplanes, helicopters, and airports is dangerous and illegal,' the agency said in its statement. The FAA is using several large drones and about 100 smaller, commercial off-the-shelf drones to test the effectiveness of three different detection and tracking systems: Remote ID provides identification and location information from drones in flight that can be received by other parties through a broadcast signal. Acoustic arrays pick up the sound made by drones, detecting their presence and calculating position and which way they are headed. X-Band radars give operators an active as opposed to passive detection and tracking capability. This is especially important for drones that are not emitting any radio frequency emissions. To see how these systems work against drones of varying sizes, speeds and altitudes, the FAA is using uncrewed aerial vehicles in three groups, ranging from those weighing less than 20 pounds, traveling at speeds 100 knots and operating below 1,200 feet to those weighing less than 1,320 pounds, travel at speeds less than 250 knots and operate below 18.000 feet. The commercial off-the-shelf drones include DJI Mavic Pro, Parrot Anafi, Skydio 2+, Skyfront Perimeter and DIY X6 Multirotor models. The larger drones are the NAVMAR Tigershark and the SpektreWorks Cobalt. Though there were thousands of reported drone sighing over New Jersey and other areas in the northeast late last year, an FAA spokesman told us on Tuesday that the decision to hold these tests in Cape May is coincidental. It was selected 'primarily [because of] proximity to the FAA Technical Center near Atlantic City,' the spokesman explained. The FAA conducted the first of these off-airport tests in Alaska in January 2023. Additional testing will take place in New Mexico, North Dakota and Mississippi later this year. The metrics for success and timeline to present analyzed data remain unclear. Though unrelated, these tests come as the origin and nature of drones seen over sensitive U.S. facilities at home and abroad, as well as those spotted over civilian areas in and around New Jersey, remain a public mystery. The FBI told us last month that its investigation into thousands of reported sightings remains ongoing. However, as we previously explained, TWZ reviewed many videos and images taken by citizens who reported seeing the drones and we have seen no proof of any widespread drone incursions. While the FBI received about 5,000 reports of drone sightings, the vast majority of material in circulation claiming to show drones actually depicted standard aircraft or, in a very limited quantity, common hobbyist drones. Still, these reports led to the FAA issuing Temporary Flight Restrictions (TFRs) over large parts of the area, mostly over power installations. Shortly after President Donald Trump returned to the White House, officials there announced that the Jersey drones were approved by the FAA 'for research and various other reasons.' We asked U.S. Northern Command (NORTHCOM), which is tasked with coordinating counter-drone activities over U.S. military bases, the level of interest it has in the FAA tests. We will update this story with any pertinent information provided. Regardless of the results of these tests, often confusing legal and regulatory hurdles limit how and when counter-drone systems that can actually effect the targeted craft can be used in the United States. Concerns about risks of collateral damage resulting from the use of anti-drone capabilities are a huge factor. As a result, the U.S. military isn't currently allowed to field kinetic and directed energy capabilities, such as laser and high-power microwave weapons, surface-to-air interceptors, and gun systems, for defending domestic bases and other critical infrastructure from rapidly growing and evolving drone threats. Instead, the focus is on electronic warfare and cyber warfare, and other 'soft-kill' options, at least for the time being. Even these capabilities are in limited use and are only even effective against a relatively narrow set of drone types. These preclusions even extend to the U.S. border with Mexico, where drug cartels have been steadily increasing their use of weaponized uncrewed aerial systems (UAS), as well as unarmed types for surveillance and smuggling. The issue has been so concerning that the U.S. Army recently deployed ground-based radars along the border to help spot and track drones as part of the continued build-up of U.S. military support there. You can read more about that in our in-depth story here. The Trump administration has made border security one of its major priorities. As a result of these limitations, Air Force Gen. Gregory M. Guillot, the NORTHCOM commander, recently testified before Congress that he is seeking an increase in the authority to shoot down drones over and around military installations. Guillot told senators that he wants increased ability to take action granted under a federal law known as '130(i).' The subsection of Title 10 of the U.S. Code (10 USC 130i) covers current authorities for the 'protection of certain facilities and assets from unmanned aircraft,' including through the use of kinetic and non-kinetic capabilities. It contains a number of specific stipulations and where and when those authorities can actually be employed. Any change in those authorities, which Congress is considering, would be on top of the Pentagon's counter-drone strategy released in the last days of the Biden administration. Some civilian airports, meanwhile, have limited capabilities — some of which are similar to those being tested — to detect and track certain kinds of drones. Just providing passive awareness of when drones are present and where is seen as a key need for some airports. Should the FAA's tests result in better ways to achieve situational awareness of these objects, and some of these systems are standardized and deployed more widely, it could go a long way toward improving the safety of flight and understanding the drone threat better. Contact the author: howard@
