(Reuters) – 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.
Canada’s approval comes ahead of a pending decision by the U.S. Food and Drug Administration, which is expected in the second quarter of 2024.
U.S. regulators over a year ago approved CSL’s Hemgenix, the first one-time gene therapy for hemophilia B.
Hemophilia is a rare genetic bleeding disorder that causes the blood to take a long time to clot due to a deficiency in one of several blood clotting factors and is predominately found in males.
(Reporting by Christy Santhosh; Editing by Shounak Dasgupta)
