{"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\n<p class=\"wp-block-paragraph\"><strong>LONDON,&nbsp;U.K.,&nbsp;25&nbsp;JUNE 2026<\/strong>&nbsp;&#8211; Ipsen (Euronext: IPN; ADR: IPSEY) announced today&nbsp;that the&nbsp;Medicines and Healthcare products Regulatory Agency (MHRA) has&nbsp;granted&nbsp;Bylvay<sup>\u00ae<\/sup> (odevixibat)&nbsp;a new indication&nbsp;for the treatment of cholestatic pruritus in Alagille&nbsp;syndrome (ALGS) in patients aged 6 months or older.<sup>1<\/sup>&nbsp;Odevixibat&nbsp;is a once-daily non-systemic ileal bile acid transport inhibitor,&nbsp;which&nbsp;blocks the ileal bile acid transporter (IBAT)&nbsp;and&nbsp;ultimately results in a decrease in serum bile acids that can form in the liver.<sup>1<\/sup>&nbsp;<\/p>\n\n\n\n<p class=\"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>&nbsp;Liver 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&nbsp;cholestasis, usually within the first few months of life and as many as 88% also present with severe, intractable pruritus.<sup>5,6<\/sup>&nbsp;The estimated global incidence of ALGS is 3 in&nbsp;100,000&nbsp;live births.<sup>4<\/sup>&nbsp;&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u201cFor those affected by biliary complications from ALGS, be they children, young adults or their&nbsp;carers, 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&nbsp;carers,&#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&nbsp;<\/p>\n\n\n\n<p class=\"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;&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The marketing authorisation&nbsp;of&nbsp;odevixibat&nbsp;was based on the ASSERT Phase III clinical trial data.<sup>2<\/sup>&nbsp;ASSERT is the world\u2019s first and only Phase III trial completed in patients with ALGS. These data&nbsp;demonstrated&nbsp;statistically significant and clinically meaningful improvements from baseline to month 6 in scratching severity for patients on&nbsp;odevixibat&nbsp;versus placebo. This was&nbsp;observed&nbsp;rapidly and&nbsp;maintained&nbsp;over the period of the study. A statistically significant reduction in serum bile acid concentration at the end of treatment was also&nbsp;demonstrated&nbsp;for patients on&nbsp;odevixibat&nbsp;versus placebo, with improvements in multiple observer-reported sleep parameters. The overall incidence of treatment-emergent adverse events with&nbsp;odevixibat&nbsp;was&nbsp;similar to&nbsp;placebo, with a low drug-related&nbsp;diarrhoea&nbsp;rate in patients with ALGS.<sup>&nbsp;<\/sup>&nbsp;<\/p>\n\n\n\n<p class=\"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&nbsp;represents&nbsp;our 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.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Odevixibat&nbsp;was&nbsp;also&nbsp;granted&nbsp;MHRA&nbsp;marketing authorisation&nbsp;in 2021&nbsp;and recommended by&nbsp;the National Institute for Health and Care Excellence (NICE)&nbsp;in 2022&nbsp;for the treatment of&nbsp;all types of&nbsp;progressive familial intrahepatic cholestasis in people 6 months and&nbsp;older.<sup>7<\/sup>&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>About&nbsp;Bylvay<sup>\u00ae<\/sup> (odevixibat)<sup>1<\/sup>&nbsp;&nbsp;<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bylvay&nbsp;(odevixibat) is a once-daily non-systemic IBAT inhibitor. It was&nbsp;approved&nbsp;in 2024&nbsp;under exceptional circumstances in the E.U.&nbsp;for the treatment of cholestatic pruritus in ALGS in patients aged 6 months or older.&nbsp;Odevixibat&nbsp;was 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.&nbsp;Odevixibat&nbsp;has received orphan exclusivity for the treatment of PFIC in the E.U. and in the U.S. In June 2023&nbsp;odevixibat&nbsp;was 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.&nbsp;<\/p>\n\n\n\n<p class=\"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\n\n<p class=\"wp-block-paragraph\"><strong>About ASSERT<sup>2<\/sup>&nbsp;<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ASSERT is a double-blind, randomised, placebo-controlled trial designed to evaluate the safety and efficacy of 120 \u00b5g\/kg\/day&nbsp;odevixibat&nbsp;for 24 weeks in relieving pruritus in patients with ALGS with 32 sites across North America, Europe, Middle&nbsp;East&nbsp;and 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&nbsp;the primary endpoint showing statistically significant improvement in pruritus as measured by the PRUCISION Observer-Reported Outcome scratching score (0-4 point&nbsp;scale), from baseline at month 6 (weeks 21 to 24), compared&nbsp;with&nbsp;the placebo arm (p=0.002). More than 90% of patients were pruritus responders (\u22651 point change at any time&nbsp;during&nbsp;24 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&nbsp;with&nbsp;the placebo arm p=0.001). Statistically significant improvements in multiple sleep parameters were&nbsp;observed&nbsp;as early as weeks 1-4 compared&nbsp;with&nbsp;patients on placebo,&nbsp;with 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.&nbsp;Odevixibat&nbsp;had an overall adverse event incidence&nbsp;similar to&nbsp;placebo and a low incidence of drug-related&nbsp;diarrhoea&nbsp;(11.4% vs. 5.9% placebo).&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Full results of the ASSERT study&nbsp;were&nbsp;published in the&nbsp;<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>&nbsp;in April 2024.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Important safety information and recommendations for the use of&nbsp;odevixibat&nbsp;will 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:&nbsp;<a href=\"http:\/\/www.ema.europa.eu\/\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>http:\/\/www.ema.europa.eu<\/strong><\/a>&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>About Ipsen&nbsp;<\/strong><\/p>\n\n\n\n<p class=\"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&nbsp;fuelled&nbsp;by internal and external innovation and supported by&nbsp;nearly 100&nbsp;years of development experience and global hubs in the U.S.,&nbsp;France&nbsp;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.&nbsp;<\/p>\n\n\n\n<p class=\"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&nbsp;<strong><a href=\"https:\/\/www.ipsen.com\/uk-ireland\/\">https:\/\/www.ipsen.com\/uk-ireland\/<\/a><\/strong>.&nbsp;&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Ipsen contacts<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Media (Local)&nbsp;<\/strong><\/p>\n\n\n\n<p class=\"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\n\n<p class=\"wp-block-paragraph\">Fi Warren&nbsp; | <strong><a href=\"mailto:fi.warren@envisionpharma.com\">fi.warren@envisionpharma.com<\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Tom Clare-Ducler&nbsp; | <strong><a href=\"mailto:tom.clare-ducler@envisionpharma.com\">tom.clare-ducler@envisionpharma.com<\/a><\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Disclaimers and\/or forward-looking statements&nbsp;<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The forward-looking statements,&nbsp;objectives&nbsp;and targets&nbsp;contained&nbsp;herein&nbsp;are based on Ipsen\u2019s management strategy, current&nbsp;views&nbsp;and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those&nbsp;anticipated&nbsp;herein.&nbsp;All of&nbsp;the 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,&nbsp;\u2018anticipates\u2019 and \u2018expects\u2019 and similar expressions are intended to&nbsp;identify&nbsp;forward-looking statements, including Ipsen\u2019s expectations&nbsp;regarding&nbsp;future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without&nbsp;taking into account&nbsp;external-growth assumptions and potential future acquisitions, which may alter these parameters. These&nbsp;objectives&nbsp;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&nbsp;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&nbsp;fail to&nbsp;achieve its&nbsp;objectives&nbsp;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&nbsp;favorable&nbsp;results obtained during preclinical trials will be confirmed&nbsp;subsequently&nbsp;during clinical trials, or that the results of clinical trials will be sufficient to&nbsp;demonstrate&nbsp;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&nbsp;set forth in&nbsp;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 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&nbsp;position&nbsp;or performance. Ipsen expressly&nbsp;disclaims&nbsp;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,&nbsp;assumptions&nbsp;or 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&nbsp;March\u00e9s&nbsp;Financiers. 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&nbsp;<strong><a href=\"https:\/\/www.ipsen.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">ipsen.com<\/a><\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>References<\/strong><\/p>\n\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\n<p class=\"wp-block-paragraph\">BYL-ALL-UK-000004<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">June 2026<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>LONDON,&nbsp;U.K.,&nbsp;25&nbsp;JUNE 2026&nbsp;&#8211; Ipsen (Euronext: IPN; ADR: IPSEY) announced today&nbsp;that the&nbsp;Medicines and Healthcare products Regulatory Agency (MHRA) has&nbsp;granted&nbsp;Bylvay\u00ae (odevixibat)&nbsp;a new indication&nbsp;for the treatment of cholestatic pruritus in Alagille&nbsp;syndrome (ALGS) in patients aged 6 months or older.1&nbsp;Odevixibat&nbsp;is a once-daily non-systemic ileal bile acid transport inhibitor,&nbsp;which&nbsp;blocks the ileal bile acid transporter (IBAT)&nbsp;and&nbsp;ultimately 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 v27.7 - 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\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"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\" \/>\n<meta property=\"og:description\" content=\"LONDON,&nbsp;U.K.,&nbsp;25&nbsp;JUNE 2026&nbsp;&#8211; Ipsen (Euronext: IPN; ADR: IPSEY) announced today&nbsp;that the&nbsp;Medicines and Healthcare products Regulatory Agency (MHRA) has&nbsp;granted&nbsp;Bylvay\u00ae (odevixibat)&nbsp;a new indication&nbsp;for the treatment of cholestatic pruritus in Alagille&nbsp;syndrome (ALGS) in patients aged 6 months or older.1&nbsp;Odevixibat&nbsp;is a once-daily non-systemic ileal bile acid transport inhibitor,&nbsp;which&nbsp;blocks the ileal bile acid transporter (IBAT)&nbsp;and&nbsp;ultimately results in a decrease in serum\" \/>\n<meta property=\"og:url\" content=\"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:site_name\" content=\"UK Ireland\" \/>\n<meta property=\"article:modified_time\" content=\"2026-06-25T09:42:35+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"9 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"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\\\/\",\"url\":\"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\\\/\",\"name\":\"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\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.ipsen.com\\\/uk-ireland\\\/#website\"},\"datePublished\":\"2026-06-25T09:38:37+00:00\",\"dateModified\":\"2026-06-25T09:42:35+00:00\",\"breadcrumb\":{\"@id\":\"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\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"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\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"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\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.ipsen.com\\\/uk-ireland\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"U.K.\u00a0MHRA\u202fgrants\u202fmarketing authorisation for\u202fIpsen\u2019s\u00a0Bylvay\u00ae\u202f(odevixibat) for cholestatic pruritus in Alagille\u00a0syndrome, a rare liver disease\u00a0\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.ipsen.com\\\/uk-ireland\\\/#website\",\"url\":\"https:\\\/\\\/www.ipsen.com\\\/uk-ireland\\\/\",\"name\":\"UK Ireland\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\\\/\\\/www.ipsen.com\\\/uk-ireland\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.ipsen.com\\\/uk-ireland\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/www.ipsen.com\\\/uk-ireland\\\/#organization\",\"name\":\"UK Ireland\",\"url\":\"https:\\\/\\\/www.ipsen.com\\\/uk-ireland\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/www.ipsen.com\\\/uk-ireland\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/www.ipsen.com\\\/uk-ireland\\\/wp-content\\\/uploads\\\/sites\\\/19\\\/2024\\\/10\\\/Logo-Ipsen-new.svg\",\"contentUrl\":\"https:\\\/\\\/www.ipsen.com\\\/uk-ireland\\\/wp-content\\\/uploads\\\/sites\\\/19\\\/2024\\\/10\\\/Logo-Ipsen-new.svg\",\"caption\":\"UK Ireland\"},\"image\":{\"@id\":\"https:\\\/\\\/www.ipsen.com\\\/uk-ireland\\\/#\\\/schema\\\/logo\\\/image\\\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"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","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"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\/","og_locale":"en_US","og_type":"article","og_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","og_description":"LONDON,&nbsp;U.K.,&nbsp;25&nbsp;JUNE 2026&nbsp;&#8211; Ipsen (Euronext: IPN; ADR: IPSEY) announced today&nbsp;that the&nbsp;Medicines and Healthcare products Regulatory Agency (MHRA) has&nbsp;granted&nbsp;Bylvay\u00ae (odevixibat)&nbsp;a new indication&nbsp;for the treatment of cholestatic pruritus in Alagille&nbsp;syndrome (ALGS) in patients aged 6 months or older.1&nbsp;Odevixibat&nbsp;is a once-daily non-systemic ileal bile acid transport inhibitor,&nbsp;which&nbsp;blocks the ileal bile acid transporter (IBAT)&nbsp;and&nbsp;ultimately results in a decrease in serum","og_url":"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\/","og_site_name":"UK Ireland","article_modified_time":"2026-06-25T09:42:35+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"9 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"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\/","url":"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\/","name":"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","isPartOf":{"@id":"https:\/\/www.ipsen.com\/uk-ireland\/#website"},"datePublished":"2026-06-25T09:38:37+00:00","dateModified":"2026-06-25T09:42:35+00:00","breadcrumb":{"@id":"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\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["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\/"]}]},{"@type":"BreadcrumbList","@id":"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\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.ipsen.com\/uk-ireland\/"},{"@type":"ListItem","position":2,"name":"U.K.\u00a0MHRA\u202fgrants\u202fmarketing authorisation for\u202fIpsen\u2019s\u00a0Bylvay\u00ae\u202f(odevixibat) for cholestatic pruritus in Alagille\u00a0syndrome, a rare liver disease\u00a0"}]},{"@type":"WebSite","@id":"https:\/\/www.ipsen.com\/uk-ireland\/#website","url":"https:\/\/www.ipsen.com\/uk-ireland\/","name":"UK Ireland","description":"","publisher":{"@id":"https:\/\/www.ipsen.com\/uk-ireland\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.ipsen.com\/uk-ireland\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.ipsen.com\/uk-ireland\/#organization","name":"UK Ireland","url":"https:\/\/www.ipsen.com\/uk-ireland\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.ipsen.com\/uk-ireland\/#\/schema\/logo\/image\/","url":"https:\/\/www.ipsen.com\/uk-ireland\/wp-content\/uploads\/sites\/19\/2024\/10\/Logo-Ipsen-new.svg","contentUrl":"https:\/\/www.ipsen.com\/uk-ireland\/wp-content\/uploads\/sites\/19\/2024\/10\/Logo-Ipsen-new.svg","caption":"UK Ireland"},"image":{"@id":"https:\/\/www.ipsen.com\/uk-ireland\/#\/schema\/logo\/image\/"}}]}},"parsely":{"version":"1.1.0","canonical_url":"https:\/\/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\/","smart_links":{"inbound":0,"outbound":0},"traffic_boost_suggestions_count":0,"meta":{"@context":"https:\/\/schema.org","@type":"NewsArticle","headline":"U.K.\u00a0MHRA\u202fgrants\u202fmarketing authorisation for\u202fIpsen\u2019s\u00a0Bylvay\u00ae\u202f(odevixibat) for cholestatic pruritus in Alagille\u00a0syndrome, a rare liver disease\u00a0","url":"http:\/\/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\/","mainEntityOfPage":{"@type":"WebPage","@id":"http:\/\/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\/"},"thumbnailUrl":"","image":{"@type":"ImageObject","url":""},"articleSection":"Rare Diseases","author":[{"@type":"Person","name":"navya"}],"creator":["navya"],"publisher":{"@type":"Organization","name":"UK Ireland","logo":""},"keywords":[],"dateCreated":"2026-06-25T09:38:37Z","datePublished":"2026-06-25T09:38:37Z","dateModified":"2026-06-25T09:42:35Z"},"rendered":"<script type=\"application\/ld+json\" class=\"wp-parsely-metadata\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"NewsArticle\",\"headline\":\"U.K.\\u00a0MHRA\\u202fgrants\\u202fmarketing authorisation for\\u202fIpsen\\u2019s\\u00a0Bylvay\\u00ae\\u202f(odevixibat) for cholestatic pruritus in Alagille\\u00a0syndrome, a rare liver disease\\u00a0\",\"url\":\"http:\\\/\\\/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\\\/\",\"mainEntityOfPage\":{\"@type\":\"WebPage\",\"@id\":\"http:\\\/\\\/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\\\/\"},\"thumbnailUrl\":\"\",\"image\":{\"@type\":\"ImageObject\",\"url\":\"\"},\"articleSection\":\"Rare Diseases\",\"author\":[{\"@type\":\"Person\",\"name\":\"navya\"}],\"creator\":[\"navya\"],\"publisher\":{\"@type\":\"Organization\",\"name\":\"UK Ireland\",\"logo\":\"\"},\"keywords\":[],\"dateCreated\":\"2026-06-25T09:38:37Z\",\"datePublished\":\"2026-06-25T09:38:37Z\",\"dateModified\":\"2026-06-25T09:42:35Z\"}<\/script>","tracker_url":"https:\/\/cdn.parsely.com\/keys\/ipsen.com\/p.js"},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.ipsen.com\/uk-ireland\/wp-json\/wp\/v2\/press_release\/3836","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.ipsen.com\/uk-ireland\/wp-json\/wp\/v2\/press_release"}],"about":[{"href":"https:\/\/www.ipsen.com\/uk-ireland\/wp-json\/wp\/v2\/types\/press_release"}],"author":[{"embeddable":true,"href":"https:\/\/www.ipsen.com\/uk-ireland\/wp-json\/wp\/v2\/users\/2"}],"version-history":[{"count":1,"href":"https:\/\/www.ipsen.com\/uk-ireland\/wp-json\/wp\/v2\/press_release\/3836\/revisions"}],"predecessor-version":[{"id":3837,"href":"https:\/\/www.ipsen.com\/uk-ireland\/wp-json\/wp\/v2\/press_release\/3836\/revisions\/3837"}],"wp:attachment":[{"href":"https:\/\/www.ipsen.com\/uk-ireland\/wp-json\/wp\/v2\/media?parent=3836"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.ipsen.com\/uk-ireland\/wp-json\/wp\/v2\/categories?post=3836"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.ipsen.com\/uk-ireland\/wp-json\/wp\/v2\/tags?post=3836"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}