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news.The FDA has approved Talecris Biotherapeutics's Gamunex, an immune globulin product for the treatment of chronic inflammatory demyelinating polyneuropathy, a rare autoimmune disorder characterized by progressive weakness and impaired sensory function in the legs and arms.
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The FDA designated Gamunex as an orphan drug to treat chronic inflammatory demyelinating polyneuropathy (CIDP). The FDA based its approval of Gamunex on clinical trials that showed Gamunex was effective at improving certain motor functions for up to 48 weeks after the initial treatment. Researchers used the inflammatory neuropathy cause and treatment scale (INCAT) to measure a patient’s ability to perform tasks such as walking and motor tasks for the hands.
The trials showed improved CIDP patient INCAT scores for muscle function after receiving Gamunex every three weeks for a 24-week period. Approximately 28 of 59 patients treated with Gamunex had improved INCAT scores compared to 13 of 58 patients treated with placebo.
In addition, patients with improved INCAT scores participated in a follow-up trial for an additional 24 weeks. Approximately 86% of the patients who continued to receive Gamunex maintained their improved INCAT scores compared to 61% of the patients who received placebo during the follow-up trial.
Gamunex is manufactured by Talecris Biotherapeutics of Research Triangle Park, North Carolina.
Jesse Goodman, director of the FDA’s Center for Biologics Evaluation and Research, said: “This approval is part of the FDA’s effort to address unmet medical needs in patients who are suffering from rare and serious diseases.”