The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of rurioctocog alfa pegol (Adynovi, Baxalta Innovations GmbH) for the treatment and prophylaxis of bleeding in patients aged 12 years and older with hemophilia A (congenital factor VIII deficiency).
Rurioctocog alfa pegol is a recombinant human factor VIII that replaces the missing coagulation factor VIII needed for effective hemostasis, the European Medicines Agency (EMA) noted in a news release.
Rurioctocog alfa pegol has been shown to prevent and control bleeding when used on demand and during surgical procedures, as seen in clinical trials in adult and pediatric patients with hemophilia A.
The most common side effects are headache, diarrhea, nausea, and rash.
Rurioctocog alfa pegol should be prescribed by physicians experienced in the treatment of hemophilia, the EMA said. It will be available as a powder and solvent for solution for injection in 250, 500, 1000, and 2000 IU.
Detailed recommendations for the use of rurioctocog alfa pegol will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.
Hemophilia is rare. According to the World Federation of Hemophilia, about 1 in 10,000 people are born with the disorder.
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