BioCentury
ARTICLE | Clinical News

OBI-1 regulatory update

December 3, 2012 8:00 AM UTC

Ipsen and Inspiration said FDA granted Fast Track designation to OBI-1 to treat acquired hemophilia A. The recombinant porcine Factor VIII is in Phase III testing for the indication, with a BLA submission to FDA slated for next half. The product has Orphan Drug designation in the U.S. and EU. ...