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Pfizer gene therapy for bleeding disorder approved in Canada
Canada: 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.
The U.S. Food and Drug Administration (FDA) had in November 2022 approved CSL's Hemgenix, making it the first one-time gene therapy for hemophilia B.
CSL had acquired exclusive global rights to Hemgenix from uniQure NV in 2021.
Pfizer is also seeking U.S. approval for its experimental antibody, marstacimab, to treat hemophilia A and B.
Hemophilia B is found in 1 in 40,000 people and represents about 15% of patients with hemophilia, according to the FDA.
The U.S. health regulator is expected to give its decision on Pfizer's therapy in the second quarter of 2024.
Original news source: https://www.reuters.com/business/healthcare-pharmaceuticals/canada-approves-pfizers-gene-therapy-bleeding-disorder-2024-01-03/
Read also: CDSCO panel Approves Pfizer's Protocol Amendment Proposal for Anti-cancer Drug Elranatamab
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751