May 8, 2008 - Talecris Biotherapeutics, Inc. announced today the U.S. Food and Drug Administration (FDA) has granted a Priority Review of Gamunex (Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).
The Priority Review designation is intended to expedite the review process for therapies that may provide a significant improvement in the treatment of serious or life-threatening diseases. Based on this Priority Review status, the FDA reviews the application with the goal of taking action within six months of the sponsor's submission of supplemental Biologics Application (sBLA).
"We are encouraged that the FDA has determined the application meets its criteria for such review, and look forward to working with the agency as it continues its review process," said Stephen Petteway, Senior Vice President, Research and Development for Talecris Biotherapeutics.
CIDP is a progressive or relapsing disease affecting two to seven individuals per 100,000 worldwide. Its course is variable. The most common symptom patients experience is progressive weakness in the arms and legs resulting in significant disability.
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