FDA grants approval to Talecris Biotherapeutics for Gamunex for neurological disorder CIDP

Sep 15 2008

Talecris Biotherapeutics, Inc. announced today the U.S. Food and Drug Administration (FDA) has granted approval 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, which can lead to severe impairment of motor skills.

Through its approval, Gamunex is the only therapy of any kind with an approved indication for the treatment of CIDP. Gamunex now has the broadest set of FDA-approved indications of any liquid Immune Globulin Intravenous (IGIV) therapy. Gamunex also becomes the first and only IVIG therapy approved to treat any neurological disorder in the United States. The FDA's ruling provides Orphan Drug Designation for Gamunex to treat CIDP. The FDA grants Orphan Drug Designation to encourage biotechnology and pharmaceutical companies to develop products that demonstrate promise for the treatment of rare diseases affecting fewer than 200,000 people in the United States. This designation grants Talecris marketing exclusivity for the treatment of CIDP with Gamunex for seven years.

"For the first time ever, U.S. patients with CIDP will finally have an FDA-approved medication to help limit peripheral nerve damage in this disorder leading to improved neurological function and quality of life," said Estelle Benson, executive and founding director of the GBS/CIDP Foundation International. Established in 1980, the Foundation is the only voluntary, nonprofit organization that provides support to Guillain-Barré Syndrome (GBS)/CIDP and their families, awards grants to researchers and offers education to the public and professional communities. "I speak on behalf of the 26,000 members of the GBS/CIDP Foundation, who are excited to learn that Talecris has established that Gamunex is a successful treatment for patients with CIDP. What good news!"

Talecris is developing programs to educate neurologists on this indication and the clinical trial which proved the efficacy supporting the new indication.

"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."

To secure the indication, Talecris conducted the first and only large-scale clinical trial for the treatment of CIDP. This study validates the long-term safety and efficacy of Gamunex as the first line and maintenance treatment for CIDP. This landmark study was published in the February 2008 issue of The Lancet Neurology.

"This was a remarkable study that provided the most compelling evidence of the short and long-term efficacy of IGIV in CIDP," said Dr. Marinos Dalakas, M.D., director of the Neuromuscular Division at Thomas Jefferson University in Philadelphia, Pa. "It is great news for the thousands of CIDP patients in this country who now have a chance to receive IGIV as an approved indication on a long-term basis and lessen the disabling effects of this disease."

http://www.talecris.com