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Medscape
27-05-2025
- Health
- Medscape
Newly Approved Mepolizumab Mitigates COPD Exacerbations
Adding mepolizumab to inhaled triple therapy significantly improved exacerbation outcomes compared with placebo in adults with chronic obstructive pulmonary disease (COPD), based on data from the MATINEE study presented at the American Thoracic Society (ATS) 2025 International Conference. Based on these findings, mepolizumab is newly approved by the US Food and Drug Administration for the treatment of COPD according to manufacturer GlaxoSmithKline. 'This decision is good news for patients because it allows more options for care, and it is good news for the future of COPD treatment in that there are now more options showing targets previously not identified that can improve patient outcomes,' said co-author Gerard J. Criner, MD, of the Lewis Katz School of Medicine at Temple University, Philadelphia, in a statement following the approval. Patients with COPD and type 2 inflammation are at an increased risk for frequent and severe exacerbations that may require hospitalization or emergency department visits, Alberto Papi, MD, of the University of Ferrara, Ferrara, Italy, and colleagues wrote in their abstract. Mepolizumab, a humanized monoclonal antibody that targets interleukin-5 (IL-5), significantly reduced COPD exacerbations in patients with COPD regardless of the history or severity of exacerbations in a phase 3 study known as MATINEE, the researchers wrote. In the study, the researchers randomized 804 adults aged 40 years or older with COPD to a subcutaneous dose of 100 mg of mepolizumab every 4 weeks for 52-104 weeks, or a placebo, in addition to the inhaled triple therapy of a fluticasone propionate dose of at least 500 μg/d or the equivalent, plus dual long-acting bronchodilators. Approximately 21% of the patients had a history of severe exacerbations in the past years. The mean age of the participants was approximately 66 years, and at least two thirds were men. Overall, patients treated with mepolizumab had a 21% reduced annualized rate of moderate to severe exacerbations compared with patients treated with placebo, with rate ratios of 0.75 and 0.79 for subgroups with and without a history of severe exacerbations, respectively. In addition, patients with a history of severe exacerbations had a 32% reduced rate of exacerbations requiring an emergency department visit or hospital stay. The results were durable as well, the researchers noted. The significant difference in exacerbation rates between patients treated with mepolizumab and those treated with placebo was observed at 1 year and continued for up to 104 weeks of treatment. The incidence of adverse events and serious adverse events was similar in the mepolizumab and placebo groups, the most common of which was exacerbation of COPD (11% and 15% for serious adverse events in the mepolizumab and placebo groups, respectively). Takeaways and Next Steps The researchers were surprised that mepolizumab's significant clinical impact on exacerbation reduction extended to such a broad group of patients with COPD, including those who did or did not have chronic bronchitis, and those with evidence of emphysema, Criner said in an interview. 'That mepolizumab could decrease emergency room visits and hospitalization is a significant benefit for patients,' he added. Mepolizumab made all its primary and key secondary end points with a robust safety profile, said Criner. 'Patients with COPD who have type 2 inflammation can benefit from biologic therapy, regardless of the severity of underlying airflow obstruction with or without the absence of chronic bronchitis or emphysema to reduce moderate and severe exacerbations,' he said. Additional research should target different pathways and patients who have inflammation with COPD, such as types 1 and 3, Criner noted. Approval Sparks Enthusiasm 'I'm excited to have another option to treat COPD patients who have elevated eosinophils and frequent exacerbations,' said study co-author Meilan Han, MD, of the University of Michigan, Ann Arbor, Michigan, in an interview. 'I'd like additional research to help us understand which patients experience the best response in terms of lung function and symptoms,' she added. The approval will change care of patients with COPD who are already maximized on inhaler therapies and continue to have exacerbations, 'as this is the only biologic approved for patients with blood eosinophils <= 300 cells/µL,' said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview. 'The cost could be prohibitive (annual cost is almost $50,000 per year); so patients should explore insurance coverage, manufacturer assistance programs, nonprofit financial support, and discount cards to reduce their out-of-pocket expenses for mepolizumab,' she said. 'The MATINEE study was important because, despite optimal triple inhaler therapy, many high-risk patients continue to experience frequent COPD exacerbations. This trial evaluated whether adding a new therapy can further reduce exacerbations in this high-risk COPD population,' said Baldomero. However, as with other biologics, when or whether mepolizumab can be safely discontinued, and whether the risk for COPD exacerbations will return upon stopping remains unclear, said Baldomero. 'Additionally, there is limited evidence to guide whether inhaler therapies can be withdrawn while on biologics, and more research is needed to determine optimal treatment duration,' she said. Expanded MATINEE Findings Offer More Insights Several other studies of MATINEE findings were presented at the meeting. In one study, data showed that mepolizumab reduced exacerbations in patients with cardiovascular comorbidities compared with placebo. Post hoc analyses of data from the MATINEE study also were presented at the meeting to examine the effectiveness of mepolizumab in various subgroups. In one post hoc analysis, patients treated with mepolizumab had lower mean healthcare resource use per exacerbation in terms of emergency department visits, urgent care/outpatient clinic visits, and days in intensive care than patients treated with placebo. Another analysis of MATINEE study data showed that, compared with placebo, mepolizumab significantly improved exacerbation rates in patients with severely restricted airflow based on the GOLD criteria. An additional post hoc analysis showed that, compared with placebo, mepolizumab's association with improved exacerbation rates was consistent regardless of duration of COPD. Mepolizumab has been developed for the treatment of a range of IL-5 mediated diseases associated with type 2 inflammation and is also approved for use in the United States and Europe for severe asthma, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome, and chronic rhinosinusitis with nasal polyps, according to manufacturer GlaxoSmithKline. The MATINEE study was funded by GlaxoSmithKline. Criner disclosed receiving consulting fees and research funds from GlaxoSmithKline. Han disclosed serving as a consultant for GlaxoSmithKline and multiple relationships with pharmaceutical companies outside of the MATINEE study.
Yahoo
02-05-2025
- Business
- Yahoo
AstraZeneca's triple-combo triumphs in two Phase III asthma trials
AstraZeneca's triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) has met the primary endpoints in two Phase III asthma trials. Breztri met primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines, in the Phase III KALOS (NCT04609878) and LOGOS (NCT04609904) trials in patients with uncontrolled asthma. KALOS and LOGOS were randomised, double-blind trials that enrolled a total of 4,434 patients with asthma to investigate Breztri as a potential treatment. Director of the Respiratory Unit, CardioRespiratory Department, S. Anna University Hospital, Ferrara, Italy, Professor Alberto Papi said: 'Despite advancements in asthma treatments, millions of patients remain uncontrolled, which can cause frequent breathlessness, coughing and wheezing, significantly impacting their ability to perform daily activities. "The results from the KALOS and LOGOS trials are exciting and demonstrate the potential of Breztri to evolve the standard of care to more effectively treat asthma in a single inhaled triple therapy for patients who remain uncontrolled with dual maintenance therapy.' Breztri did not show any unexpected safety or tolerability concerns in either trial. Full data from the two studies will be shared with regulatory authorities and presented at an upcoming medical meeting. Breztri is an inhaled triple-combination therapy approved for the treatment of chronic obstructive pulmonary disease. It received approval from the US Food and Drug Administration (FDA) on 24 July 2020 based on positive data from the Phase III ETHOS trial (NCT02465567), which showed a significant reduction in exacerbations compared with dual-combination therapies. GlobalData forecasts that sales of Breztri will reach $2.32bn in 2030, with estimates indicating the drug will reach blockbuster status in 2025. GlobalData is the parent company of Clinical Trials Arena. Elsewhere in asthma, GSK is hoping for approval of its depemokimab as an add-on treatment for asthma after two Phase III trials, SWIFT-1 and SWIFT-2, met their primary endpoints. The FDA has set a Prescription Drug User Fee Act date of 16 December 2025. "AstraZeneca's triple-combo triumphs in two Phase III asthma trials" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Business Wire
02-05-2025
- Health
- Business Wire
BREZTRI met primary endpoints in KALOS and LOGOS Phase III trials in asthma
WILMINGTON, Del.--(BUSINESS WIRE)--Positive high-level results from the Phase III KALOS and LOGOS trials in patients with uncontrolled asthma showed that AstraZeneca's fixed-dose triple-combination therapy BREZTRI AEROSPHERE (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) met all primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines. KALOS and LOGOS were replicate, randomized, double-blind trials designed to investigate BREZTRI as a potential treatment for asthma. 1,2 The trials evaluated the efficacy and safety of BREZTRI versus maintenance treatment with ICS/LABA in adults and adolescents with uncontrolled asthma. 1,2 Asthma is a common, chronic respiratory disease characterized by inflammation and muscle tightening in the airway (bronchoconstriction), which can make it difficult to breathe. 3 As many as 262 million people worldwide are affected by asthma, 3 and it is estimated that nearly half of those treated with dual therapy remain uncontrolled, which can significantly limit lung function and decrease quality of life. 4,5 Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara, and Director of the Respiratory Unit, CardioRespiratory Department, S. Anna University Hospital, Ferrara, Italy, and primary investigator, said: 'Despite advancements in asthma treatments, millions of patients remain uncontrolled, which can cause frequent breathlessness, coughing and wheezing, significantly impacting their ability to perform daily activities. The results from the KALOS and LOGOS trials are exciting and demonstrate the potential of budesonide/glycopyrronium/formoterol to evolve the standard of care to more effectively treat asthma in a single inhaled triple therapy for patients who remain uncontrolled with dual maintenance therapy.' Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: 'We are excited by the positive results from the KALOS and LOGOS trials, which demonstrate that BREZTRI could help improve the lives of the millions of patients living with asthma. These asthma data build on the well-established profile of BREZTRI in COPD, and we look forward to sharing with regulatory authorities to bring this important medicine to a wider group of patients.' There were no new safety or tolerability signals identified for BREZTRI in KALOS or LOGOS. Full results from the two Phase III trials will be shared with regulatory authorities and presented at an upcoming medical meeting. BREZTRI is an inhaled triple-combination therapy approved for the treatment of chronic obstructive pulmonary disease (COPD) in adults in more than 80 countries worldwide including the US, EU, China and Japan. IMPORTANT SAFETY INFORMATION BREZTRI AEROSPHERE ® (budesonide, glycopyrrolate, and formoterol fumarate) Inhalation Aerosol BREZTRI is contraindicated in patients who have a hypersensitivity to budesonide, glycopyrrolate, formoterol fumarate, or product excipients BREZTRI is not indicated for treatment of asthma. Long-acting beta2-adrenergic agonist (LABA) monotherapy for asthma is associated with an increased risk of asthma-related death. These findings are considered a class effect of LABA monotherapy. When a LABA is used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone. Available data do not suggest an increased risk of death with use of LABA in patients with COPD BREZTRI should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition BREZTRI is NOT a rescue inhaler. Do NOT use to relieve acute symptoms; treat with an inhaled short-acting beta2-agonist BREZTRI should not be used more often than recommended; at higher doses than recommended; or in combination with LABA-containing medicines, due to risk of overdose. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs Oropharyngeal candidiasis has occurred in patients treated with orally inhaled drug products containing budesonide. Advise patients to rinse their mouths with water without swallowing after inhalation Lower respiratory tract infections, including pneumonia, have been reported following ICS. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap Due to possible immunosuppression, potential worsening of infections could occur. Use with caution. A more serious or fatal course of chickenpox or measles can occur in susceptible patients Particular care is needed for patients transferred from systemic corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to BREZTRI Hypercorticism and adrenal suppression may occur with regular or very high dosage in susceptible individuals. If such changes occur, consider appropriate therapy Caution should be exercised when considering the coadministration of BREZTRI with long-term ketoconazole and other known strong CYP3A4 Inhibitors. Adverse effects related to increased systemic exposure to budesonide may occur If paradoxical bronchospasm occurs, discontinue BREZTRI immediately and institute alternative therapy Anaphylaxis and other hypersensitivity reactions (eg, angioedema, urticaria or rash) have been reported. Discontinue and consider alternative therapy Use caution in patients with cardiovascular disorders, especially coronary insufficiency, as formoterol fumarate can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles Decreases in bone mineral density have been observed with long-term administration of ICS. Assess initially and periodically thereafter in patients at high risk for decreased bone mineral content Glaucoma and cataracts may occur with long-term use of ICS. Worsening of narrow-angle glaucoma may occur, so use with caution. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use BREZTRI long term. Instruct patients to contact a healthcare provider immediately if symptoms occur Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to contact a healthcare provider immediately if symptoms occur Use caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis or unusually responsive to sympathomimetic amines Be alert to hypokalemia or hyperglycemia Most common adverse reactions in a 52-week trial (incidence ≥ 2%) were upper respiratory tract infection (5.7%), pneumonia (4.6%), back pain (3.1%), oral candidiasis (3.0%), influenza (2.9%), muscle spasms (2.8%), urinary tract infection (2.7%), cough (2.7%), sinusitis (2.6%), and diarrhea (2.1%). In a 24-week trial, adverse reactions (incidence ≥ 2%) were dysphonia (3.3%) and muscle spasms (3.3%) BREZTRI should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors and tricyclic antidepressants, as these may potentiate the effect of formoterol fumarate on the cardiovascular system BREZTRI should be administered with caution to patients being treated with: Strong cytochrome P450 3A4 inhibitors (may cause systemic corticosteroid effects) Adrenergic drugs (may potentiate effects of formoterol fumarate) Xanthine derivatives, steroids, or non-potassium sparing diuretics (may potentiate hypokalemia and/or ECG changes) Beta-blockers (may block bronchodilatory effects of beta-agonists and produce severe bronchospasm) Anticholinergic-containing drugs (may interact additively). Avoid use with BREZTRI Use BREZTRI with caution in patients with hepatic impairment, as budesonide and formoterol fumarate systemic exposure may increase. Patients with severe hepatic disease should be closely monitored INDICATION BREZTRI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). LIMITATIONS OF USE Not indicated for the relief of acute bronchospasm or for the treatment of asthma. Please see full BREZTRI Prescribing Information, including Patient Information. You may report side effects related to AstraZeneca products. Notes Asthma Asthma is a prevalent, chronic respiratory disease affecting as many as 262 million people worldwide, 3 including over 25 million in the US. 6 When uncontrolled, inflammation and muscle tightening in the airway (bronchoconstriction) may cause wheezing, breathlessness, chest tightness, coughing, and even death. 3,7 Many patients remain uncontrolled despite the availability of standard of care medicines and continue to experience significant limitations on lung function and reduced quality of life. 4,5 KALOS and LOGOS Phase III trials KALOS and LOGOS are replicate confirmatory, randomized, double-blind, double-dummy, parallel group, multi-centre, 24-to-52-week variable length Phase III trials to assess the efficacy and safety of BGF (320/28.8/9.6μg and 320/14.4/9.6μg) compared with two fixed-dose, dual-combination therapies of budesonide, an ICS, and formoterol fumarate, a LABA: PT009 (in anAEROSPHERE inhaler) and SYMBICORT pressurized metered-dose inhaler (pMDI). 1,2 KALOS and LOGOS included approximately 4,400 randomized patients. The trial design was optimized to evaluate the 320/28.8/9.6μg dose of BGF. The primary efficacy endpoints for the two individual trials were a change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24 and trough FEV1 over 12-24 weeks and over 24 weeks. 1,2 In addition to the two registrational trials, KALOS and LOGOS, two qualifying trials, LITHOS and VATHOS, 8,9 also met their primary endpoints. LITHOS and VATHOS included approximately 1,000 randomized patients. AstraZeneca in Respiratory & Immunology Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals is a key disease area and growth driver to the Company. AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases. AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 125 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit and follow us on social media @AstraZeneca. References Study to Assess PT010 in Adult and Adolescent Participants with Inadequately Controlled Asthma (KALOS) [Online]. Available at: [Last accessed: May 2025]. Study to Assess PT010 in Adult and Adolescent Participants with Inadequately Controlled Asthma (LOGOS) [Online]. Available at: [Last accessed: May 2025]. Global Asthma Network. The Global Asthma Report 2022. [Online]. Available at: [Last accessed: May 2025]. Davis J, et al. Burden of asthma among patients adherent to ICS/LABA: A real-world study. J Asthma. 2019 Mar;56(3):332-340. Buhl R, et al. One-year follow up of asthmatic patients newly initiated on treatment with medium- or high-dose inhaled corticosteroid-long-acting β2-agonist in UK primary care settings. Respir Med. 2020 Feb: 162:105859. U.S. Centers for Disease Control and Prevention (CDC). Most Recent National Asthma Data. [Online]. Available at: [Last accessed: May 2025]. Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014; 40 (4): 364-372. A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants with Inadequately Controlled Asthma (LITHOS) [Online]. Available at: [Last Accessed: May 2025]. A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants with Inadequately Controlled Asthma (VATHOS) [Online]. Available at: [Last Accessed: May 2025]. AstraZeneca Data on File. 2025. REF-270910.
Reuters
02-05-2025
- Health
- Reuters
AstraZeneca's 'smoker's lung' therapy meets main goals of late-stage asthma trials
May 2 (Reuters) - AstraZeneca (AZN.L), opens new tab said on Friday its triple-combination inhaler Breztri Aerosphere met all main goals in two late-stage trials for uncontrolled asthma, showing clinically meaningful improvement in lung function. The Anglo-Swedish drugmaker's therapy, already approved for the treatment of Chronic Obstructive Pulmonary Disease or "smoker's lung", was being compared with a dual-combination maintenance treatment in the trials. here. The results come as AstraZeneca targets $80 billion in revenue by 2030, after first-quarter sales this week missed expectations on weaker oncology drug performance. Asthma is a common but chronic lung disease that makes breathing difficult due to inflammation and muscle tightening. It affected 262 million people and caused 455,000 deaths in 2019, according to the World Health Organization, opens new tab. "The results from the ... trials are exciting and demonstrate the potential of budesonide/glycopyrronium/formoterol to evolve the standard of care to more effectively treat asthma in a single inhaled triple therapy," said Alberto Papi, primary investigator of the studies, referring to the compounds in Breztri Aerosphere. AstraZeneca said on Friday it would share detailed results from the trials with authorities and seek to broaden approvals for Breztri, which brought in sales of $978 million last year and competes with GSK's Trelegy Ellipta.
