{"id":17845,"date":"2023-06-16T17:37:15","date_gmt":"2023-06-16T17:37:15","guid":{"rendered":"https:\/\/interhospi.com\/?p=17845"},"modified":"2023-06-17T04:25:13","modified_gmt":"2023-06-17T04:25:13","slug":"ema-authorises-marketing-application-for-efanesoctocog-alfa-for-treatment-of-haemophilia-a","status":"publish","type":"post","link":"https:\/\/interhospi.com\/ema-authorises-marketing-application-for-efanesoctocog-alfa-for-treatment-of-haemophilia-a\/","title":{"rendered":"EMA authorises marketing application for efanesoctocog alfa\u00a0for treatment of haemophilia A"},"content":{"rendered":"
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EMA authorises marketing application for efanesoctocog alfa\u00a0for treatment of haemophilia A<\/h1>\/ in Product News<\/a> <\/span><\/span><\/header>\n<\/div><\/section>
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The European Medicines Agency (EMA) has accepted and validated a marketing authorisation application from pharma company Sobi for efanesoctocog alfa, a new class of high-sustained FVIII developed for the treatment of people with haemophilia A of all age groups. The application is based on data from the pivotal XTEND-1 phase 3 study in adults and adolescents and the XTEND-Kids paediatric study in patients <12 years of age. Efanesoctocog alfa was approved by the US FDA as ALTUVIIIO earlier this year.<\/h3>\n

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\u201cSobi aims to raise the standard of care for rare disease patients around the globe,\u201d said Tony Hoos, MD, PhD, Head of Research & Development and Chief Medical Officer. This \u201cannouncement may represent a crucial step towards improving the lives of people with haemophilia A through a potential new treatment option. We look forward to working closely with EMA during their review of our dossier to allow timely access for the haemophilia community in Europe.\u201d<\/p>\n<\/div><\/section>
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Haemophilia A is a rare, genetic disorder in which the ability of a person’s blood to clot is impaired due to a lack of factor VIII. Haemophilia A occurs in about one in 5,000 male births annually, and more rarely in females. People with haemophilia can experience bleeding episodes including life-threatening haemorrhages, acute and chronic pain, irreversible joint damage with disability and negative impacts on quality of life. Despite advancements in treatment made in recent years, a large unmet medical need still exists and requires further improvement in the standard of care.<\/p>\n

Learn more at www.sobi.com<\/a>
\nDigital issue: Please click here<\/a> for more information<\/p>\n<\/div><\/section>
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