Sobi’s ALTUVOCT receives EU marketing authorization

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Sobi® has received Marketing Authorization from the European Commission for ALTUVOCT™ (efanesoctocog alfa) for the treatment of hemophilia A. ALTUVOCT is a sustained factor VIII replacement therapy for all ages that can significantly reduce bleeds with once-weekly prophylaxis. The EMA also endorsed ALTUVOCT’s orphan drug designation, granting a 10-year market exclusivity period. Studies have shown that ALTUVOCT prophylaxis provides improved protection against bleeds compared to other factor VIII products. Hemophilia A affects about one in 5,000 male births annually and can lead to life-threatening hemorrhages. ALTUVOCT was previously approved in the US and has shown significant clinical benefits.

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