Landmark study demonstrates Gamunex improves health-related quality of life in patients...( RESEARCH TRIANGLE PARK N.C. (April ...),Health

RESEARCH TRIANGLE PARK, N.C. (April 23, 2009) Talecris Biotherapeutics, Inc. today announced the publication of the health-related quality of life results from the largest clinical trial ever conducted in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) in the April 14, 2009 issue of Neurology. The data demonstrate that long-term treatment with Gamunex (Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified) improves and maintains health-related quality of life in patients with CIDP.

The analysis of health-related quality-of-life endpoints showed that patients who received Gamunex experienced greater improvements in physical and mental component scores compared with placebo, as measured by the Short-Form-36 (SF-36) health survey, one of the most widely used measures of health-related quality of life. Improvements in all SF-36 domains favored Gamunex versus placebo, with physical functioning, role-physical, social functioning and mental health reaching significance.

"The data provide the rationale for administering maintenance doses of Gamunex every three weeks as a means of improving health-related quality of life and preventing relapse of symptoms," according to Ingemar Merkies, M.D., Ph.D., Department of Neurology, Erasmus Medical Center, Rotterdam and Spaarne Hospital Hoofddorp, the Netherlands. The study was funded by Talecris Biotherapeutics.

CIDP is a debilitating nerve disease that results in progressive weakness in the arms and legs, causing significant disability for many individuals. Gamunex is the first and only FDA-approved product for the treatment of CIDP.

"Until now, there has been no FDA-approved dosing regimen for an effective course of intravenous immune globulin therapy to reduce neuromuscular disability and improve quality of life in patients with CIDP," Merkies said. "Data from this trial provide an effective regimen with Gamunex to achieve improvem
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