Ipsen and Inspiration Biopharmaceuticals have announced FDA Fast Track status to an intravenous recombinant porcine factor VIII, OBI-1, for acquired hemophilia A therapy.
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.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-awards-fast-track-status-to-acquired-hemophilia-a-drug-candidate-211112
