The European Medicines Agency (EMA) has accepted and verified Sobi’s marketing authorisation application for a new factor VIII (FVIII), efanesoctocog alfa, to treat haemophilia A patients of all ages.
The application is supported by results from the Phase III XTEND-1 trial in adults and adolescents and backed by the XTEND-Kids paediatric trial in patients aged under 12 years.
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In February 2023, the US Food and Drug Administration approved efanesoctocog alfa as ALTUVIIIO.
Efanesoctocog alfa is a new and investigational recombinant FVIII therapy with the potential to provide near-normal factor activity levels for significant portions of the week, thereby enhancing bleed protection through a once-a-week dose for haemophilia A patients.
Haemophilia A is a rare genetic disorder in which blood-clotting ability is impaired because of the absence of FVIII.
It affects around one in 5,000 males at birth per year but is rare in females.
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By GlobalDataSobi research and development head and chief medical officer Tony Hoos stated: “Sobi aims to raise the standard of care for rare disease patients around the globe.
“Today’s announcement 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 the EMA during their review of our dossier to allow timely access for the haemophilia community in Europe.”
