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news.Ipsen and Inspiration Biopharmaceuticals have announced FDA Fast Track status to an intravenous recombinant porcine factor VIII, OBI-1, for acquired hemophilia A therapy.
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The drug candidate is being studied to treat acquired hemophilia A individuals who developed inhibitory antibodies in opposition to their inborn FVIII.
Inspiration considers submitting a biologics license application (BLA) in the first half of 2013 to the FDA.
OBI-1 gained orphan drug status from FDA in March 2004 and from EMA in October 2010.
Fast track is a process designed to facilitate the development, and advance the review of drugs to treat serious diseases for which no other drug either exists or works as well.