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Pfizer (NYSE:PFE) said it has received FDA approval for its one-time gene therapy Beqvez for the treatment of certain adults with hemophilia B.
The drugmaker said the therapy is aimed at enabling patients to produce factor IX in their own bodies rather than relying on regular intravenous transfusions of the blood-clotting protein.
Pfizer said it is also launching a warranty program for the therapy based on durability of patient response. The warranty is intended to provide greater certainty about the treatment to payers and financial protection against efficacy failure.
Beqvez is currently being reviewed by EU regulators and was recently approved for use in Canada.
Pfizer added that it also has gene therapy candidates in Phase 3 development for the treatment of hemophilia A and Duchenne muscular dystrophy.