FDA Approves Talecris’s Neurologic Drug

October 8, 2008

The US Food and Drug Administration has approved Talecris Biotherapeutics’ (Research Triangle Park, NC) Gamunex as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP).

The US Food and Drug Administration has approved Talecris Biotherapeutics’ (Research Triangle Park, NC) Gamunex 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.

Gamunex, which was granted orphan drug status, 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 orphan drug designation grants Talecris marketing exclusivity for the treatment of CIDP with Gamunex for seven years.

Talecris’s release