Pfizer said on Wednesday that Canada’s health regulator approved its gene therapy for the treatment of a rare inherited bleeding disorder called hemophilia B ahead of a U.S. decision.
The approval was based on late-stage trials that showed a single dose of the therapy, to be sold under the brand name Beqvez, was superior to the current standard of care which involves replacing a blood-clotting protein called factor IX, according to the company’s release.
The therapy is for patients over 18 living with moderately severe to severe hemophilia B.
The U.S. Food and Drug Administration (FDA) had in November 2022 approved pharmaceutical company CSL’s
