Hemophilia A drug heads toward approval in Europe

Emicizumab looks like it’s headed toward approval in Europe for the prevention and reduction of bleeding episodes in patients with hemophilia A with factor VIII inhibitors.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended granting marketing authorization to the drug in January 2018, according to a statement. The recommendation will now be considered by the European Commission.

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Emicizumab, which is marketed in the United States as Hemlibra, was approved by the Food and Drug Administration for adult and pediatric patients with hemophilia A with Factor VIII inhibitors in November. It is the first monoclonal antibody to be recommended for use in patients with hemophilia A with inhibitors, says the statement.

mschneider@frontlinemedcom.com