Talecris Biotherapeutics, Inc. received approval from the FDA for Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a debilitating neurological disorder that results in muscle weakness and fatigue and can cause severe impairment of motor skills. Gamunex is the first therapy approved for the treatment of CIDP as well as the first IVIG therapy approved in the U.S. to treat a neurological disorder.
   
The FDA’s ruling provides Orphan Drug Designation for Gamunex, which grants Talecris marketing exclusivity for the treatment of CIDP for seven years. This approval was based on results from the first and only large-scale trial for the treatment of CIDP. The study validates the long-term safety and efficacy of Gamunex as the first line and maintenance treatment for CIDP, according to a Talecris statement.
   
“We are proud to be the first company to prove the efficacy of an IGIV product for CIDP,” said Lawrence Stern, president and chief executive officer for Talecris Biotherapeutics. “For people with this neurological disorder, Gamunex provides a safe and effective method of treatment. To help provide patients access to this important therapy, we are working to substantially increase supplies of Gamunex in 2009.”