{"id":3836,"date":"2026-06-25T11:38:37","date_gmt":"2026-06-25T09:38:37","guid":{"rendered":"https:\/\/www.ipsen.com\/uk-ireland\/?post_type=press_release&#038;p=3836"},"modified":"2026-06-25T11:42:35","modified_gmt":"2026-06-25T09:42:35","slug":"u-k-mhra-grants-marketing-authorisation-for-ipsens-bylvay-odevixibat-for-cholestatic-pruritus-in-alagille-syndrome-a-rare-liver-diseas","status":"publish","type":"press_release","link":"https:\/\/www.ipsen.com\/uk-ireland\/press-releases\/u-k-mhra-grants-marketing-authorisation-for-ipsens-bylvay-odevixibat-for-cholestatic-pruritus-in-alagille-syndrome-a-rare-liver-diseas\/","title":{"rendered":"U.K.\u00a0MHRA\u202fgrants\u202fmarketing authorisation for\u202fIpsen\u2019s\u00a0Bylvay\u00ae\u202f(odevixibat) for cholestatic pruritus in Alagille\u00a0syndrome, a rare liver disease\u00a0"},"content":{"rendered":"\n<ul class=\"wp-block-list\">\n<li>Bylvay<sup>\u00ae<\/sup>&nbsp;(odevixibat)&nbsp;is&nbsp;indicated&nbsp;for&nbsp;the treatment of&nbsp;cholestatic pruritus in children from&nbsp;6&nbsp;months with the rare liver condition Alagille&nbsp;syndrome<sup>1&nbsp;<\/sup><\/li>\n\n\n\n<li>Marketing authorisation for&nbsp;odevixibat&nbsp;was&nbsp;based on data from ASSERT,&nbsp;the only Phase III trial completed in patients with Alagille&nbsp;syndrome<sup>2<\/sup>&nbsp;<\/li>\n\n\n\n<li>Alagille&nbsp;syndrome is an inherited rare, genetic disorder associated with chronic cholestasis&nbsp;\u2013 which can cause fibrosis and progressive liver disease \u2013 and severe,&nbsp;intractable&nbsp;pruritus<sup>3<\/sup>&nbsp;<\/li>\n\n\n\n<li>The estimated global incidence of Alagille&nbsp;syndrome is 3 in 100,000 live births<sup>4<\/sup>&nbsp;<\/li>\n<\/ul>\n\n\n<p class=\"heading-para wp-block-paragraph\"><strong>LONDON,\u00a0U.K.,\u00a025\u00a0JUNE 2026<\/strong>\u00a0&#8211; Ipsen (Euronext: IPN; ADR: IPSEY) announced today\u00a0that the\u00a0Medicines and Healthcare products Regulatory Agency (MHRA) has\u00a0granted\u00a0Bylvay<sup>\u00ae<\/sup> (odevixibat)\u00a0a new indication\u00a0for the treatment of cholestatic pruritus in Alagille\u00a0syndrome (ALGS) in patients aged 6 months or older.<sup>1<\/sup>\u00a0Odevixibat\u00a0is a once-daily non-systemic ileal bile acid transport inhibitor,\u00a0which\u00a0blocks the ileal bile acid transporter (IBAT)\u00a0and\u00a0ultimately results in a decrease in serum bile acids that can form in the liver.<sup>1<\/sup>\u00a0<\/p>\n\n<p class=\"heading-para wp-block-paragraph\">ALGS is an inherited rare, genetic disorder that can affect multiple organs including the liver, heart, skeleton, eyes and kidneys.<sup>3<\/sup>\u00a0Liver damage may result from having fewer than normal, narrowed or malformed bile ducts, which leads to a build-up of toxic bile acid, known as cholestasis and this in turn can cause fibrosis and progressive liver disease.<sup>3<\/sup> Approximately 95% of patients with the condition present with chronic\u00a0cholestasis, usually within the first few months of life and as many as 88% also present with severe, intractable pruritus.<sup>5,6<\/sup>\u00a0The estimated global incidence of ALGS is 3 in\u00a0100,000\u00a0live births.<sup>4<\/sup>\u00a0\u00a0<\/p>\n\n<p class=\"heading-para wp-block-paragraph\">\u201cFor those affected by biliary complications from ALGS, be they children, young adults or their\u00a0carers, ALGS can be all-consuming. It presents early on in the first few months of life and severe pruritus is common, with children scratching to the point of bleeding, causing emotional distress and sleep disturbance for the child and their\u00a0carers,&#8221; said Professor Palak Trivedi, Professor of Cholestatic and Immune-Mediated Liver Diseases and Honorary Consultant Hepatologist at the National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre (BRC). \u201cThe availability of a new treatment option that has been shown to reduce the itch and improve sleep is very welcome news for the ALGS community.\u201d\u00a0<\/p>\n\n<p class=\"heading-para wp-block-paragraph\">&#8220;Alagille syndrome can have a devastating impact on those affected &#8211; for the infants and young children suffering with symptoms, as well as the parents and carers that can so often feel helpless,&#8221; said Michelle Wilkins, Head of Children and Families Service at the British Liver Trust. \u201cThis decision recognises the unmet need that exists within the Alagille community and the potential benefits a new treatment option can bring.&#8221;\u00a0<\/p>\n\n<p class=\"heading-para wp-block-paragraph\">The marketing authorisation\u00a0of\u00a0odevixibat\u00a0was based on the ASSERT Phase III clinical trial data.<sup>2<\/sup>\u00a0ASSERT is the world\u2019s first and only Phase III trial completed in patients with ALGS. These data\u00a0demonstrated\u00a0statistically significant and clinically meaningful improvements from baseline to month 6 in scratching severity for patients on\u00a0odevixibat\u00a0versus placebo. This was\u00a0observed\u00a0rapidly and\u00a0maintained\u00a0over the period of the study. A statistically significant reduction in serum bile acid concentration at the end of treatment was also\u00a0demonstrated\u00a0for patients on\u00a0odevixibat\u00a0versus placebo, with improvements in multiple observer-reported sleep parameters. The overall incidence of treatment-emergent adverse events with\u00a0odevixibat\u00a0was\u00a0similar to\u00a0placebo, with a low drug-related\u00a0diarrhoea\u00a0rate in patients with ALGS.<sup>\u00a0<\/sup>\u00a0<\/p>\n\n<p class=\"heading-para wp-block-paragraph\">\u201cAt Ipsen, we are dedicated to helping people with rare liver disease live life to the fullest every day. This U.K. marketing authorisation\u00a0represents\u00a0our ongoing commitment to expanding therapeutic possibilities where solutions are scarce and the stakes are high.\u201d said Dr Ian Gray, U.K. &amp; Ireland Medical Director at Ipsen.\u00a0<\/p>\n\n<p class=\"heading-para wp-block-paragraph\">Odevixibat\u00a0was\u00a0also\u00a0granted\u00a0MHRA\u00a0marketing authorisation\u00a0in 2021\u00a0and recommended by\u00a0the National Institute for Health and Care Excellence (NICE)\u00a0in 2022\u00a0for the treatment of\u00a0all types of\u00a0progressive familial intrahepatic cholestasis in people 6 months and\u00a0older.<sup>7<\/sup>\u00a0<\/p>\n\n<p class=\"heading-para wp-block-paragraph\"><strong>About\u00a0Bylvay<sup>\u00ae<\/sup> (odevixibat)<sup>1<\/sup>\u00a0\u00a0<\/strong><\/p>\n\n<p class=\"heading-para wp-block-paragraph\">Bylvay\u00a0(odevixibat) is a once-daily non-systemic IBAT inhibitor. It was\u00a0approved\u00a0in 2024\u00a0under exceptional circumstances in the E.U.\u00a0for the treatment of cholestatic pruritus in ALGS in patients aged 6 months or older.\u00a0Odevixibat\u00a0was approved in June 2021 in the E.U. as the first drug treatment option for all types of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older, and in the U.S. as the first drug treatment option for patients 3 months of age and older living with cholestatic pruritus due to PFIC.\u00a0Odevixibat\u00a0has received orphan exclusivity for the treatment of PFIC in the E.U. and in the U.S. In June 2023\u00a0odevixibat\u00a0was approved in the U.S. for the treatment of cholestatic pruritus in patients from 12 months of age with ALGS and received orphan exclusivity for ALGS.\u00a0<\/p>\n\n<p class=\"heading-para wp-block-paragraph\">Odevixibat was granted MHRA marketing authorisation for the treatment of all types of PFIC in patients 6 months and older in 2021 and recommended by the NICE in this indication in 2022.<sup>7<\/sup> <\/p>\n\n<p class=\"heading-para wp-block-paragraph\"><strong>About ASSERT<sup>2<\/sup>\u00a0<\/strong><\/p>\n\n<p class=\"heading-para wp-block-paragraph\">ASSERT is a double-blind, randomised, placebo-controlled trial designed to evaluate the safety and efficacy of 120 \u00b5g\/kg\/day\u00a0odevixibat\u00a0for 24 weeks in relieving pruritus in patients with ALGS with 32 sites across North America, Europe, Middle\u00a0East\u00a0and Asia Pacific. The trial enrolled patients aged 0 to 17 years of age with a genetically confirmed diagnosis of ALGS. In the primary analysis, the study met\u00a0the primary endpoint showing statistically significant improvement in pruritus as measured by the PRUCISION Observer-Reported Outcome scratching score (0-4 point\u00a0scale), from baseline at month 6 (weeks 21 to 24), compared\u00a0with\u00a0the placebo arm (p=0.002). More than 90% of patients were pruritus responders (\u22651 point change at any time\u00a0during\u00a024 weeks). The study also met the key secondary endpoint showing a statistically significant reduction in serum bile acid concentration from baseline to the average of weeks 20 and 24 (compared\u00a0with\u00a0the placebo arm p=0.001). Statistically significant improvements in multiple sleep parameters were\u00a0observed\u00a0as early as weeks 1-4 compared\u00a0with\u00a0patients on placebo,\u00a0with continued improvement through week 24. In the study, there were no patient discontinuations and 96% of patients rolled over into the open-label extension study.\u00a0Odevixibat\u00a0had an overall adverse event incidence\u00a0similar to\u00a0placebo and a low incidence of drug-related\u00a0diarrhoea\u00a0(11.4% vs. 5.9% placebo).\u00a0<\/p>\n\n<p class=\"heading-para wp-block-paragraph\">Full results of the ASSERT study\u00a0were\u00a0published in the\u00a0<a href=\"https:\/\/www.thelancet.com\/journals\/langas\/article\/PIIS2468-1253(24)00074-8\/fulltext\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Lancet, Gastroenterology &amp; Hepatology<\/strong><\/a>\u00a0in April 2024.\u00a0<\/p>\n\n<p class=\"heading-para wp-block-paragraph\">Important safety information and recommendations for the use of\u00a0odevixibat\u00a0will be detailed in the Summary of Product Characteristics (SmPC), published in the European public assessment report and available in all official EU languages. The full SmPC will be found at:\u00a0<a href=\"http:\/\/www.ema.europa.eu\/\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>http:\/\/www.ema.europa.eu<\/strong><\/a>\u00a0<\/p>\n\n<p class=\"heading-para wp-block-paragraph\"><strong>About Ipsen\u00a0<\/strong><\/p>\n\n<p class=\"heading-para wp-block-paragraph\">We 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\u00a0fuelled\u00a0by internal and external innovation and supported by\u00a0nearly 100\u00a0years of development experience and global hubs in the U.S.,\u00a0France\u00a0and 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.\u00a0<\/p>\n\n<p class=\"heading-para wp-block-paragraph\">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\u00a0<strong><a href=\"https:\/\/www.ipsen.com\/uk-ireland\/\">https:\/\/www.ipsen.com\/uk-ireland\/<\/a><\/strong>.\u00a0\u00a0<\/p>\n\n<p class=\"heading-para wp-block-paragraph\"><strong>Ipsen contacts<\/strong><\/p>\n\n<p class=\"heading-para wp-block-paragraph\"><strong>Media (Local)\u00a0<\/strong><\/p>\n\n<p class=\"heading-para wp-block-paragraph\">Sam Howland | <a href=\"mailto:sam.howland@ipsen.com\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>sam.howland@ipsen.com<\/strong><\/a><\/p>\n\n<p class=\"heading-para wp-block-paragraph\">Fi Warren\u00a0 | <strong><a href=\"mailto:fi.warren@envisionpharma.com\">fi.warren@envisionpharma.com<\/a><\/strong><\/p>\n\n<p class=\"heading-para wp-block-paragraph\">Tom Clare-Ducler\u00a0 | <strong><a href=\"mailto:tom.clare-ducler@envisionpharma.com\">tom.clare-ducler@envisionpharma.com<\/a><\/strong><\/p>\n\n<p class=\"heading-para wp-block-paragraph\"><strong>Disclaimers and\/or forward-looking statements\u00a0<\/strong><\/p>\n\n<p class=\"heading-para wp-block-paragraph\">The forward-looking statements,\u00a0objectives\u00a0and targets\u00a0contained\u00a0herein\u00a0are based on Ipsen\u2019s management strategy, current\u00a0views\u00a0and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those\u00a0anticipated\u00a0herein.\u00a0All of\u00a0the above risks could affect Ipsen\u2019s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words \u2018believes\u2019,\u00a0\u2018anticipates\u2019 and \u2018expects\u2019 and similar expressions are intended to\u00a0identify\u00a0forward-looking statements, including Ipsen\u2019s expectations\u00a0regarding\u00a0future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without\u00a0taking into account\u00a0external-growth assumptions and potential future acquisitions, which may alter these parameters. These\u00a0objectives\u00a0are 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\u00a0uncertainties, 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\u00a0fail to\u00a0achieve its\u00a0objectives\u00a0and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that\u00a0favorable\u00a0results obtained during preclinical trials will be confirmed\u00a0subsequently\u00a0during clinical trials, or that the results of clinical trials will be sufficient to\u00a0demonstrate\u00a0the 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\u00a0set forth in\u00a0the 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 and risks arising from unexpected regulatory or political changes such as changes in tax regulation and regulations on trade and tariffs, such as protectionist measures, especially in the United States; 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\u2019s 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\u2019s 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\u2019s 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\u2019s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen\u2019s business, financial\u00a0position\u00a0or performance. Ipsen expressly\u00a0disclaims\u00a0any 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,\u00a0assumptions\u00a0or circumstances on which any such statements are based, unless so required by applicable law. Ipsen\u2019s business is subject to the risk factors outlined in its registration documents filed with the French Autorit\u00e9 des\u00a0March\u00e9s\u00a0Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen\u2019s latest Universal Registration Document, available on\u00a0<strong><a href=\"https:\/\/www.ipsen.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">ipsen.com<\/a><\/strong>.<\/p>\n\n<p class=\"heading-para wp-block-paragraph\"><strong>References<\/strong><\/p>\n\n\n<ol class=\"wp-block-list\">\n<li>Summary of Product Characteristics. Bylvay. Available upon request.<\/li>\n\n\n\n<li>Ovchinsky N, et al. Efficacy and safety of odevixibat in patients with Alagille syndrome (ASSRT); a phase 3, double-blind, randomized, placebo-controlled trial. Lancet Gastroenterol \/ Hepatol. 2024 doi.org\/10.1016\/S2468-1253[24]00074-8<\/li>\n\n\n\n<li>National Organization for Rare Disorders. Alagille Syndrome. Available at: Alagille Syndrome &#8211; Symptoms, Causes, Treatment | NORD. Last accessed: June 2026<\/li>\n\n\n\n<li>Leonard L. Eur J Hum Genet. 2014; 22:435. Last accessed: June 2026<\/li>\n\n\n\n<li>Singh S P. Euroasian J Hepatogastroenterol. 2018; 8[2]: 140-14<\/li>\n\n\n\n<li>Hirschfield G, Vandriel SM, Mogul D, Baek M, Vig P, Kamath BM. Liver Int. 2025; 45[2]: e16201. Last accessed: June 2026. <\/li>\n\n\n\n<li>National Institute for Health and Care Excellence. Odevixibat for treating progressive familial intrahepatic cholestasis. Available at: <a href=\"https:\/\/www.nice.org.uk\/guidance\/hst17\"><strong>https:\/\/www.nice.org.uk\/guidance\/hst17<\/strong><\/a>. Last accessed: June 2026<\/li>\n<\/ol>\n\n\n<p class=\"heading-para wp-block-paragraph\">BYL-ALL-UK-000004<\/p>\n\n<p class=\"heading-para wp-block-paragraph\">June 2026<\/p>\n\n<p class=\"heading-para wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>LONDON,\u00a0U.K.,\u00a025\u00a0JUNE 2026\u00a0&#8211; Ipsen (Euronext: IPN; ADR: IPSEY) announced today\u00a0that the\u00a0Medicines and Healthcare products Regulatory Agency (MHRA) has\u00a0granted\u00a0Bylvay\u00ae (odevixibat)\u00a0a new indication\u00a0for the treatment of cholestatic pruritus in Alagille\u00a0syndrome (ALGS) in patients aged 6 months or older.1\u00a0Odevixibat\u00a0is a once-daily non-systemic ileal bile acid transport inhibitor,\u00a0which\u00a0blocks the ileal bile acid transporter (IBAT)\u00a0and\u00a0ultimately results in a decrease in serum<\/p>\n","protected":false},"author":2,"template":"","categories":[12],"tags":[],"class_list":["post-3836","press_release","type-press_release","status-publish","hentry","category-rare-diseases","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>U.K.\u00a0MHRA\u202fgrants\u202fmarketing authorisation for\u202fIpsen\u2019s\u00a0Bylvay\u00ae\u202f(odevixibat) for cholestatic pruritus in Alagille\u00a0syndrome, a rare liver disease\u00a0 - UK Ireland<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.ipsen.com\/uk-ireland\/press-releases\/u-k-mhra-grants-marketing-authorisation-for-ipsens-bylvay-odevixibat-for-cholestatic-pruritus-in-alagille-syndrome-a-rare-liver-diseas\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" 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