In November, Inspiration Biopharmaceuticals, Inc. (Inspiration) and Ipsen recently announced that US Food and Drug Administration (FDA) granted Fast Track designation for OBI-1 for use in patients with acquired hemophilia A. OBI-1 is an intravenous recombinant porcine (pig) factor VIII (rpFVIII) product designed for the treatment of bleeding in people with hemophilia A with inhibitors and in people with acquired hemophilia.
Acquired hemophilia is a rare condition often seen in older people. It results when the body produces antibodies to clotting factors proteins such as factor V, VIII and IX. The disorder has been associated with allergic drug reactions, pregnancy and immune system disorders such as rheumatoid arthritis. In approximately half of cases, the cause is unknown.
FDA reserves Fast Track designation for a drug intended to treat a serious disease and that has a potential to fill an unmet medical need. It helps facilitate the development of new drugs and expedites their review. Marketing applications for fast track often receive priority review, shortening the review period to eight months. Inspiration intends to submit a biologics license application to the FDA in the first half of 2013.
Enrollment in a Phase III trial for OBI-1 in acquired hemophilia is ongoing. Inspiration has also initiated a second clinical trial using OBI-1 in individuals with the inherited form of hemophilia A and inhibitors to FVIII. For more information visit: http://www.clinicaltrials.gov.
Source: HeraldOnline.com, November 20, 2012