Pfizer Announces its Gene Therapy, Beqvez, Approved by US FDA

Pfizer Inc. announced that its gene therapy Beqvez (fidanacogene elaparvovec-dzkt) has been approved by the US FDA for treating adults with moderate to severe hemophilia B who undergo regular prophylaxis and are 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. Read more here.

Source: LA Kelley Communications, Inc., May 2024