Octapharma Applies to FDA for New IVIG Drug

Octapharma AG recently submitted its biological license application for Octagam 10% (human normal intravenous immunoglobulin, liquid) to the U.S. Food and Drug Administration as part of its goal to expand the company’s U.S. immune globulin therapy portfolio by early 2010. The application was submitted for the treatment of idiopathic thrombocytopenic purpura (ITP), a blood-clotting disorder that can result in excessive bruising and bleeding.

“The expected introduction of Octagam 10% will provide yet another immune globulin intravenous (IVIG) product option for patients that further builds on the success already achieved with the Octagam product line both globally and in the U.S.,” said Octapharma USA President Flemming Nielsen.

The company also recently submitted an investigational new drug (IND) application for a next-generation IVIG product for the treatment of ITP and chronic inflammatory demyelinating polyneuropathy (CIDP), a neurological disorder that progressively impairs leg and arm function. In addition, Octapharma is evaluating the efficacy of immune globulin as a treatment in new and existing conditions, including ITP, CIDP, multiple sclerosis, Alzheimer’s disease and primary immune deficiency. In February, the company started Phase II clinical trials following FDA review of its IND for Octagam 10% in mild-tomoderate Alzheimer’s disease.