Ipsen and Inspiration Biopharmaceuticals announced that Inspiration has received Fast Track designation from the FDA for OBI-1 in acquired hemophilia A. OBI-1 is an intravenous recombinant porcine factor VIII (FVIII).
In November 2010, Inspiration initiated the first pivotal study of OBI-1 for the treatment of severe bleeding in individuals with acquired hemophilia A. The Phase 3 study is a prospective, non-randomized, open-label study evaluating the efficacy of OBI-1 for the treatment of serious bleeding episodes in individuals with acquired hemophilia caused by development of autoimmune inhibitory antibodies to human FVIII. Serious bleeding episodes include those that are a threat to a patient’s life or vital organs or limbs, or which require a blood transfusion. Results from the first 12 subjects in this clinical study were announced in July 2012. Enrollment in the clinical trial is ongoing.
OBI-1 received Orphan Drug Designation from the FDA in March 2004. Inspiration intends to submit a biologics license application (BLA) to the FDA in the first half of 2013.