On Friday, Pfizer Inc. revealed that their gene therapy product, Beqvez (otherwise known as fidanacogene elaparvovec-dzkt), has received FDA approval. The drug is intended to treat adults suffering from moderate to severe hemophilia B who regularly require prophylaxis and are currently experiencing a potentially fatal bleed.
The FDA's approval was reportedly based on data from the BENEGENE-2 trial. This Phase 3 study examined the effectiveness and safety of Beqvez in adult males aged between 18 and 65 who have moderate severe to severe hemophilia B.
Additionally, Pfizer disclosed that Beqvez is currently under evaluation by the European Medicines Agency, and has recently secured approval in Canada.
