The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has awarded a positive opinion granting the marketing authorisation of Shire’s Adynovi [Antihemophilic Factor (Recombinant), PEGylated] to treat haemophilia A.
Haemophilia A is the most common type of haemophilia and a rare bleeding disorder that causes longer-than-normal bleeding due to lack of clotting factor VIII (FVIII) in the blood.
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It is an orphan disease designated by the European Commission (EC).
Adynovi is an extended half-life recombinant factor VIII (rFVIII) treatment for adults and adolescents of 12 years of age and older with haemophilia A.
Shire Global Research and Development senior vice-president and ad-interim head Howard B. Mayer said: “This positive opinion marks an important step in providing adults and adolescents with haemophilia A in Europe with the potential for a new treatment option with a twice-weekly prophylaxis dosing schedule, so patients can manage their haemophilia A care with their physicians in the way that works best for them.”
The CHMP submission was based on results obtained from three Phase III clinical trials of patients suffering from haemophilia A.
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By GlobalDataThe trials included a prospective, global, multi-centre, open label, non-randomised study of patients between 12 and 65 years of age; a prospective, uncontrolled, open-label, multi-centre study of patients of 12 years of age and younger; and an evaluation of perioperative control of haemostasis with interim study results from 15 patients with severe haemophilia A undergoing surgical procedures.
The positive opinion will be reviewed by the EC, which has the authority to grant marketing authorisation in the European Union (EU).
