In April, Inspiration Biopharmaceuticals, Inc., announced that it had submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of IB1001, its recombinant factor IX (rFIX) product for the treatment and prevention of bleeding in individuals with hemophilia B.
IB1001 is now under regulatory review in both the U.S. and Europe. Inspiration’s Marketing Authorization Application was accepted by the European Medicines Agency in September 2011 for additional review. The company is finalizing plans for additional regulatory filings and preparing for the commercial launch of IB1001. The only rFIX therapy currently on the U.S. market is BeneFIX®, manufactured by Pfizer Inc.
“The introduction of recombinant factor IX was an important step forward in the treatment of hemophilia B, but a single product is not sufficient to meet the needs of all people affected by this disease,” said John P. Butler, Inspiration's Chief Executive Officer in the press release. “At Inspiration, we are solely focused on the needs of people with hemophilia, and we are proud of the progress we have made towards bringing forward a new choice of treatment for patients. We plan to work closely with regulatory authorities both here in the U.S. and around the world to make IB1001 available as broadly and rapidly as possible.”
Source: Inspiration Biopharmaceuticals press release dated April 17, 2012