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news.Inspiration Biopharmaceuticals has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the approval of IB1001, used for the treatment and prevention of bleeding in individuals with hemophilia B.
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IB1001 is an intravenous recombinant factor IX (rFIX) protein, and has completed pivotal Phase 3 clinical studies that support the filling of the BLA.
Inspiration will receive a $35m milestone payment associated with its filing of the BLA, as per the terms of agreement with Ipsen.
Currently, the company is finalizing plans for additional regulatory filings and preparing for the commercial launch of IB1001.
Inspiration chief executive officer John P. Butler said the company plans to work with regulatory authorities both here in the US and around the world to make IB1001 available as broadly and rapidly as possible.
The initiative follows a comprehensive set of pharmacokinetics safety, and efficacy data from a Phase 3 clinical trial in people affected by hemophilia B.