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Yahoo
17-07-2025
- Health
- Yahoo
GSK's Linerixibat Poised to Address Substantial Unmet Need for the Treatment of Pruritus Associated with Primary Biliary Cholangitis, According to Spherix Global Insights
Despite new market entrants in the form of Gilead's Livdelzi and Ipsen's Iqirvo, US gastroenterologists report nearly half of PBC patients suffer from moderate to severe pruritus, underscoring an existing unmet need. EXTON, PA, July 17, 2025 (GLOBE NEWSWIRE) -- The treatment landscape for primary biliary cholangitis (PBC) has undergone a marked transformation over the past year, driven by the recent approvals of Gilead's Livdelzi (seladelpar) and Ipsen's Iqirvo (elafibranor). These additions to the therapeutic arsenal represent meaningful progress in disease management. However, new data from Spherix Global Insights' Market Dynamix™: Primary Biliary Cholangitis and Primary Sclerosing Cholangitis 2025 (US) reveal that pruritus—a persistent and often debilitating symptom—continues to pose a significant unmet need for many patients living with PBC. Among the 104 US gastroenterologists surveyed in the study, there was near-universal agreement on the importance of addressing pruritus—one of the most burdensome and distressing symptoms associated with PBC. Respondents estimated that approximately half of their PBC patients suffer from moderate to severe pruritus, a manifestation that significantly impacts quality of life and remains challenging to manage. As one specialist poignantly noted, 'Patients with cholestatic liver disease will go to the world's end to escape from pruritus and the insomnia it causes.' Most gastroenterologists surveyed also acknowledged a substantial unmet need for therapies specifically targeting PBC-associated pruritus. While Livdelzi has demonstrated a significant reduction in itch symptoms after six months of treatment, only about half of respondents reported that their patients on Livdelzi required no additional intervention for pruritus. The need for effective symptom control is even more pronounced among patients receiving Iqirvo, further highlighting the gap in adequate pruritus management and the continued demand for novel therapeutic approaches. In June, GSK announced that the FDA had accepted the New Drug Application (NDA) for its ileal bile acid transporter (IBAT) inhibitor, linerixibat, for the treatment of cholestatic pruritus in patients with PBC. The PDUFA target action date is set for March 24, 2026. Awareness of the IBAT class is already high among gastroenterologists, and most report they are likely to incorporate linerixibat into their treatment armamentarium if approved. As one specialist expressed, 'The results seem promising with a significant symptom reduction among moderate to severe pruritus. However, abdominal pain and diarrhea side effects are somewhat concerning and may limit real-world use.' Another echoed the sentiment, noting, 'It significantly improved symptoms of pruritus along with quality of life, which can be a challenging and quite debilitating symptom to treat.' If approved, linerixibat could represent a meaningful advancement for patients struggling with PBC-related pruritus—a symptom that continues to profoundly impair quality of life and remains inadequately addressed by current therapies. Spherix Global Insights will continue to closely track emerging developments across the PBC treatment landscape and pipeline through its Market Dynamix™: Primary Biliary Cholangitis and Primary Sclerosing Cholangitis service. Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a paradigm shift within the next three to five years. Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit or connect through LinkedIn. For more details on Spherix's primary market research reports and interactive dashboard offerings, visit or register here: NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and analysis addressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release. CONTACT: Jim Hickey, Gastroenterology Franchise Head Spherix Global Insights 4848794284 in to access your portfolio
Business Upturn
17-07-2025
- Health
- Business Upturn
GSK's Linerixibat Poised to Address Substantial Unmet Need for the Treatment of Pruritus Associated with Primary Biliary Cholangitis, According to Spherix Global Insights
EXTON, PA, July 17, 2025 (GLOBE NEWSWIRE) — The treatment landscape for primary biliary cholangitis (PBC) has undergone a marked transformation over the past year, driven by the recent approvals of Gilead's Livdelzi (seladelpar) and Ipsen's Iqirvo (elafibranor). These additions to the therapeutic arsenal represent meaningful progress in disease management. However, new data from Spherix Global Insights' Market Dynamix™: Primary Biliary Cholangitis and Primary Sclerosing Cholangitis 2025 (US) reveal that pruritus—a persistent and often debilitating symptom—continues to pose a significant unmet need for many patients living with PBC. Among the 104 US gastroenterologists surveyed in the study, there was near-universal agreement on the importance of addressing pruritus—one of the most burdensome and distressing symptoms associated with PBC. Respondents estimated that approximately half of their PBC patients suffer from moderate to severe pruritus, a manifestation that significantly impacts quality of life and remains challenging to manage. As one specialist poignantly noted, 'Patients with cholestatic liver disease will go to the world's end to escape from pruritus and the insomnia it causes.' Most gastroenterologists surveyed also acknowledged a substantial unmet need for therapies specifically targeting PBC-associated pruritus. While Livdelzi has demonstrated a significant reduction in itch symptoms after six months of treatment, only about half of respondents reported that their patients on Livdelzi required no additional intervention for pruritus. The need for effective symptom control is even more pronounced among patients receiving Iqirvo, further highlighting the gap in adequate pruritus management and the continued demand for novel therapeutic approaches. In June, GSK announced that the FDA had accepted the New Drug Application (NDA) for its ileal bile acid transporter (IBAT) inhibitor, linerixibat, for the treatment of cholestatic pruritus in patients with PBC. The PDUFA target action date is set for March 24, 2026. Awareness of the IBAT class is already high among gastroenterologists, and most report they are likely to incorporate linerixibat into their treatment armamentarium if approved. As one specialist expressed, 'The results seem promising with a significant symptom reduction among moderate to severe pruritus. However, abdominal pain and diarrhea side effects are somewhat concerning and may limit real-world use.' Another echoed the sentiment, noting, 'It significantly improved symptoms of pruritus along with quality of life, which can be a challenging and quite debilitating symptom to treat.' If approved, linerixibat could represent a meaningful advancement for patients struggling with PBC-related pruritus—a symptom that continues to profoundly impair quality of life and remains inadequately addressed by current therapies. Spherix Global Insights will continue to closely track emerging developments across the PBC treatment landscape and pipeline through its Market Dynamix™: Primary Biliary Cholangitis and Primary Sclerosing Cholangitis service. Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a paradigm shift within the next three to five years. Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit or connect through LinkedIn. For more details on Spherix's primary market research reports and interactive dashboard offerings, visit or register here: NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and analysis addressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
Yahoo
16-04-2025
- Business
- Yahoo
Ipsen delivers strong sales in the first quarter 2025 and confirms its full-year guidance
Total sales growth of 11.6% at CER1, or 11.7% as reported, driven by all three therapeutic areas and including an increasing contribution from Iqirvo and Bylvay. Tovorafenib regulatory submission to EMA2 for pediatric low-grade glioma. Confirmation of full-year 2025 financial guidance. PARIS, FRANCE, 16 April 2025 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents sales for the first quarter of 2025. Q1 2025 % change % change €m Actual CER1 Oncology 655.0 8.5% 8.0% Neuroscience 193.5 8.0% 9.6% Rare Disease 70.3 78.4% 74.6% Total Sales 918.8 11.7% 11.6% 'Ipsen has delivered a strong start to 2025, building further momentum in the transformation of our company,' commented David Loew, Chief Executive Officer, Ipsen. 'We continued to execute on our strategy with strong top-line growth and pipeline progression. I am pleased to see the rapid build-up of our Rare Cholestatic Liver disease franchise with two innovate medicines for five indications. 2025 is set to be an important year for Ipsen, with multiple launches underway and several milestones expected across our portfolio.'Ipsen is confirming financial guidance for full-year 2025: Total sales growth greater than 5.0%, at constant currency. Based on the average level of exchange rates in March 2025, a limited effect on total sales from currencies is expected. Core operating margin greater than 30.0% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities. Guidance includes expected negative impact on Somatuline sales due to increased generic competition in the U.S. and Europe. It excludes any impact from potential late-stage (Phase III clinical development or later) business development anticipates several key milestones across its portfolio in 2025, including: Cabometyx (CABINET trial) – Regulatory decision in the European Union for advanced pancreatic (pNETs) and extra-pancreatic (epNETs) neuroendocrine tumors (NETs). fidrisertib (FALKON trial) – Readout of the pivotal Phase IIb trial in fibrodysplasia ossificans progressiva (FOP). LANT3 (LANTIC trial) – Proof-of-concept data readout, evaluating its potential in aesthetics. The regulatory filing for tovorafenib was accepted by EMA for review in the European Union, marking an important step forward in the development of this potential treatment for pediatric low-grade glioma and reinforcing Ipsen's commitment to innovation in rare and difficult-to-treat cancers. Ipsen also initiated the entry in Phase I of IPN01195, a RAF inhibitor, complementing IPN01194, an ERK inhibitor, and tovorafenib, two other assets targeting the MAPK announced on March 19th the successful completion of its inaugural Rated Public Bond of €500 million with a coupon of 3.875%, maturing in March 2032. Following the disclosure of the Investment Grade ratings from S&P and Moody's, this transaction was very well received and largely oversubscribed by a diversified and solid institutional investor base. This transaction is an important component of Ipsen's refinancing plan which included the successful renewal of €1,5 billion syndicated Revolving Credit Facility, extending Ipsen's debt maturity profile.A conference call and webcast for investors and analysts will begin today at 2pm CET. Participants can access the call and its details by registering here; webcast details can be found intends to publish its half-year results on July 31st, financial figures are in € millions (€m). The performance shown covers the three-month period to 31 March 2025 (Q1 2025, the quarter), compared to the three-month period to 31 March 2024 (Q1 2024), unless stated are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit Deojee +33 6 69 09 12 96 MediaSally Bain +1 857 320 0517Anne Liontas +33 7 67 34 72 96 Disclaimers and/or forward-looking statements The forward-looking statements, objectives and targets contained herein are based on Ipsen's management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen's future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words 'believes', 'anticipates' and 'expects' and similar expressions are intended to identify forward-looking statements, including Ipsen's expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen's patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen's activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen's partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen's business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen's business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen's latest Universal Registration Document, available on 1 At constant exchange rates (CER), which exclude any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.2 EMA: European Medicines Agency 3 Long-acting neurotoxinAttachment Ipsen PR_Q1 2025_15042025Sign in to access your portfolio
Yahoo
08-04-2025
- Health
- Yahoo
Edinburgh woman's 'menopause symptoms' turned out to be chronic liver disease
An Edinburgh woman who thought her liver disease symptoms was the menopause has opened up on her shocking diagnosis. Jo McCardle, 52, said she went through a 'really dark time' after she was told she had Primary Biliary Cholangitis - a liver disease that can get progressively worse over time. She first noticed symptoms back in 2022 including fatigue and brain fog. She also wasn't articulate and stopped paying attention to detail. READ MORE: Heartbreak for family in Edinburgh hospital after 'squint' in baby's eye is rare cancer READ MORE: Worried East Lothian locals 'can't have visitors' due to hoarding neighbour Speaking to Edinburgh Live, the Global Medical Affairs Manager said she put her feelings down to menopause before a blood test determined her diagnosis. She is now on lifetime medication but said she will not let the disease 'define her'. Jo added: "It has been such a journey for me. At the time, I had an incident at work and I had to go to A&£. "I had my bloods taken and they said there was something wrong with my blood results and I was referred to my GP. They phoned me after and said I had something serious going on but I didn't know what it was. "I was referred to a liver specialist and it was a really dark time for me. I didn't want to tell family everything that was going on. I did look up a lot of things but I didn't know what was happening - I just knew it was going to be a bad outcome. "Around three or four months later, I got the liver test to check the condition. I was relieved I wasn't dying but I did feel really ashamed at first. I remember feeling tired a lot, I had a lot of brain fog and I was forgetting things. "I didn't fell well at all and realised I wasn't paying attention to detail anymore. I just thought it was menopause I was going through." Jo was able to catch the disease at a good stage and is thankful her liver was in a treatable condition. She continued: "Luckily, although I have the condition it was picked up at a good stage and if it hadn't been, it could have been really damaged. It was pure luck I got the blood test done at work to pick it up. "This is just my normal now and I don't want to be defined by this - I want to live my life. It has really been a journey for me but it's made me appreciate everything a lot more. Join Edinburgh Live's Whatsapp Community hereand get the latest news sent straight to your messages. "Having the disease doesn't mean your life is over - I still have a very functioning job role and there is hope after the diagnosis of a long term condition. PBC is a lifelong condition associated with severe fatigue and persistent, debilitating itch – but can worsen over time and cause liver failure.. New medication Iqirvo has recently been approved which could help those impacted across Scotland. Around 1,900 people and 9 in 10 people living with PBC are woman, with most menopausal age around 40-60 years.
