The U.S. Food and Drug Administration has put its stamp of formal approval on a neurological disorder treatment from RTP-based
The treatment, called Gamunex, is intended to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a disorder that leads to muscle weakness and fatigue and impairs motor skills.
Gamunex is a liquid immune globulin intravenous (IGIV) therapy. The FDA granted Talecris’ treatment approval as an “orphan drug,” a designation for compounds designed to treat diseases affecting fewer than 200,000 people. Talecris will receive market exclusivity 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, who is executive and founding director of the
Talecris issued Benson’s statement as part of its announcement about the FDA decision.
“For people with this neurological disorder, Gamunex provides a safe and effective method of treatment,” said Lawrence Stern, chief executive officer at Talecris. “To help provide patients access to this important therapy, we are working to substantially increase supplies of Gamunex in 2009.”
CSL Ltd., an Australian-based company, is in the process of buying Talecris for $3.1 billion in cash.
Talecris, which is based in RTP and operates a huge blood plasma therapeutics production facility in Clayton, is owned by Cerberus partners and Ampersand Ventures. The company has some 2,000 employees in North Carolina and operates six plasma-collection centers in the state.