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.

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    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 U.S. Food and Drug Administration (FDA) had in November 2022 approved pharmaceutical company CSL’s product Hemgenix, making it the first one-time gene therapy for hemophilia B.

    CSL had acquired exclusive global rights to Hemgenix from gene therapy maker uniQure NV in 2021.

    CBC News reached out to Health Canada for comment on Pfizer’s announcement.

    The U.S. health regulator is expected to give its decision on Pfizer’s therapy in the second quarter of 2024.


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