Pfizer gene therapy gets hemophilia B approval in Canada, setting stage for CSL rivalry

Pfiz­er has se­cured an ap­proval for its gene ther­a­py for he­mo­phil­ia B in Cana­da, months ahead of an ex­pect­ed de­ci­sion in the US.

The ap­proval sets up a ri­val­ry with CSL Behring’s gene ther­a­py Hem­genix, which was cleared for use in the US in No­vem­ber 2022 and in Cana­da this past Oc­to­ber. Hem­genix was the first gene ther­a­py ap­proved for he­mo­phil­ia B, a rare ge­net­ic dis­ease caused by the de­fi­cien­cy of a pro­tein called fac­tor IX, which helps blood clot. Pa­tients are at risk of dan­ger­ous bleeds and of­ten need life-long treat­ment with fac­tor IX.

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