Regulatory briefs from Ipsen/Inspiration, Janssen and Astellas

French drugmaker Ipsen (Euronext: IPN) and partner USA-based privately-held Inspiration Biopharmaceuticals have received fast track designation from the US Food and Drug Administration for OBI-1 in acquired hemophilia A. OBI-1, an intravenous recombinant porcine factor VIII (FVIII), is being evaluated for the treatment of individuals with acquired hemophilia A, who have developed inhibitory antibodies (inhibitors) against their innate FVIII.

Marketing applications for fast track development programs are likely to be considered appropriate for priority review, which implies an abbreviated review time of eight months, noted Ipsen. Inspiration intends to submit a biologics license application (BLA) to the FDA in the first half of 2013. OBI-1 received orphan drug designation from the FDA in March 2004 and from the European Medicines Agency in October 2010.

Under the Chapter 11 procedure announced late last month (The Pharma Letter November 1), Ipsen and Inspiration are proposing to jointly sell their hemophilia assets including OBI-1 and IB1001, an rrFIX for hemophilia B, plus the OBI-1 industrial facility in Milford.