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Title: FDA Approves Treatment for Chronic Inflammatory Demyelinating Polyneuropathy
URL: http://www.pslgroup.com/dg/22C14E.htm
Doctor's Guide
September 12, 2008

ROCKVILLE, Md -- September 12, 2008 -- The US Food and Drug Administration (FDA) announced that it has approved an immune globulin product called Gamunex for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

"This approval is part of the FDA's effort to address unmet medical needs in patients who are suffering from rare and serious diseases," said Jesse L. Goodman, MD, FDA's Center for Biologics Evaluation and Research, Rockville, Maryland.

The FDA based its approval of this product on clinical trials that showed it 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 the immune globulin product every 3 weeks for a 24-week period. Of the 59 patients treated with the immune globulin product, 28 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. Of those, 86% maintained their improved INCAT scores compared to 61% of the patients who received placebo during the follow-up trial.

Adverse reactions were similar to those of other immune globulin products and included headache, fever, increased blood pressure, rash, joint pain, chills, back pain, nausea, and lightheadedness.

SOURCE: US Food and Drug Administration

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