Inspiration Biopharmaceuticals announced that it has submitted a Biologics License Application (BLA) to the FDA for the approval of IB1001 for the treatment and prevention of bleeding in individuals with hemophilia B.
The IB1001 BLA filing includes a comprehensive set of pharmacokinetics safety, and efficacy data from a Phase 3 clinical trial in people affected by hemophilia B. A surgery substudy was also included.
IB1001 is an intravenous recombinant factor IX product.
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