Shire receives CHMP backing for EU approval of haemophilia drug Adynovi

Shire has announced that its new haemophilia A therapy Adynovi has been recommended for European regulatory approval.

The extended half-life recombinant Factor VIII treatment has been issued with a positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), recommending the drug for approval across the EU.

It is intended for adults and adolescents aged 12 and older living with haemophilia A for on-demand and prophylactic use, and has demonstrated its safety and efficacy in three phase III clinical studies.

Haemophilia A is considered a designated orphan disease in Europe and causes longer-than-normal bleeding due to lack of clotting factor VIII in the blood. More than 150,000 people worldwide are affected.

Dr Howard Mayer, senior vice-president and interim head of global research and development at Shire, 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."

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