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Published: January 4, 2024
American pharmaceutical company Pfizer announced on January 3rd that the Canadian health regulatory authority had approved its gene therapy to treat a rare hereditary bleeding disorder called Hemophilia B before the United States announced a similar decision.
The approval was based on late-stage trials that showed a single dose of the gene therapy, which will be sold under the brand name Beqvees, was superior to the current standard of care involving replacement of a blood clotting protein called Factor IX, according to a statement from the multinational pharmaceutical company.
The treatment was intended for patients over 18 years old suffering from moderate to severe Hemophilia B.
The U.S. Food and Drug Administration (FDA) approved CSL’s Hemgenix product in November 2022, which became the first single-dose gene therapy for Hemophilia B.
CSL also obtained exclusive global rights for Hemgenix from the gene therapy maker uniQure NV in 2021.
Pfizer is also seeking U.S. approval for its experimental antibody, Marstacimab, to treat Hemophilia types A and B.
Beqvez was listed as an approved product in the online database of the Canadian Ministry of Health. The Canadian Broadcasting Corporation (CBC) contacted health authorities for comment on Pfizer’s announcement.
Hemophilia is a genetic disorder that causes blood not to clot normally, according to the Canadian Hemophilia Society. Patients with this condition bleed spontaneously, excessively, or for longer than usual.
One in every 40,000 people suffers from Hemophilia B, representing about 15 percent of hemophilia patients, according to the U.S. Food and Drug Administration.
U.S. health authorities are also expected to make a decision regarding Pfizer’s treatment in mid-2024.
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