Obizur

Lollar, J

Obizur®, a recombinant B domain deleted porcine (pig) factor VIII (rpfVIII), was approved by the FDA in October 2014 and launched in early 2015. Obizur® was developed to help the approximately twenty-five percent of severe Hemophilia A patients with neutralizing antibodies or “inhibitors“ to human factor VIII as well as to treat a rare but life threatening autoimmune condition caused when an individual not born a hemophiliac suddenly develops inhibitors to his own factor VIII, so called “acquired hemophiliacs.“ These “inhibitor” patients are resistant to first line treatments. Emory originally licensed this technology to Octagen Corporation, the assets of which were purchased by the French drug maker Ipsen, which continued development of this product until 2013, when Baxter Healthcare took on the final stages of development and regulatory approvals. When Baxter spun off its biopharmaceutical division, Baxalta took over marketing OBIZUR® in July 2015.