Pfizer's Beqvez Receives FDA Approval For Treatment Of Adults With Hemophilia B

(RTTNews) - Friday, Pfizer Inc. (PFE) announced that its gene therapy Beqvez also known as fidanacogene elaparvovec-dzkt has been approved by the FDA for treating adults with moderate to severe hemophilia B who undergo regular prophylaxis and is facing a current life-threatening bleed.

The company indicated that the FDA's decision was influenced by data from the BENEGENE-2 trial, a Phase 3 study that investigated the efficacy and safety of Beqvez in adult males between 18 and 65 years old with moderately severe to severe hemophilia B.

Pfizer also mentioned that Beqvez is undergoing evaluation by the European Medicines Agency and has recently been given the green light in Canada.