Saturday, October 4, 2008

Help For Peripheral Neuropathy Victims-Gamunex Approved by FDA



Great news!

FDA Approval of Gamunex: What This Means for Our Community
By Tina M. Tockarshewsky

The recent approval by the FDA for Gamunex (Immune Globulin Intravenous [Human] 10% Caprylate/Chromatography Purified) as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) represents a significant moment for our neuropathy community. CIDP is a particularly debilitating type of neuropathy, resulting in muscle weakness and fatigue and possible motor function impairment. With so many types of neuropathies and so few treatments, to finally have a treatment indicated for a well-classified, specific type of neuropathy affecting thousands of Americans is indeed a breakthrough, even if only for the CIDP community.

A large-scale clinical trial conducted by Talecris Biotherapeutics to study the safety and efficacy of Gamunex preceded this indication, and the results demonstrated the short and long-term efficacy of IVIG in treating CIDP. Now, thousands of CIDP patients in the U.S. will have long-term access to IVIG to mitigate CIDP’s disabling effects, promising them a way to limit their peripheral nerve damage and improve their quality of life. The FDA’s approval grants Orphan Drug Designation for Gamunex, a designation acknowledging that this is a treatment for a rare disease impacting fewer than 200,000 Americans and giving Talecris marketing exclusivity for the treatment of CIDP with Gamunex for seven years.

Medical news like this gives our entire community renewed hope that current clinical trials and studies will yield similar results in the very near future!

Neuropathy on Sirius Satellite Radio’s "Doctor Radio" Program

On September 24, 2008, a Neuropathy Association spokeperson, was invited by Sirius Satellite Radio to participate in its "Doctor Radio" show on channel 114.

Bridget T. Carey, M.D., assistant professor of Neurology and assistant attending neurologist at the New York Presbyterian Weill Cornell Medical Center (a Neuropathy Association-Designated Neuropathy Center), spoke on behalf of the Association to highlight the prevalence of peripheral neuropathy and its many different causes.

Neuropathy Centers Launched at Ohio State University and Saint Louis University

With the just announced addition of Ohio State University and Saint Louis University to The Neuropathy Association’s network of affiliate neuropathy centers, the Association prepares for the next phase of its centers network, now totaling 12 centers nationwide.

Led by Drs. John T. Kissel and Victoria Lawson, the neuropathy center at The Ohio State University serves the neuropathy community in a key region. Florian P. Thomas, M.D., M.A., Ph.D. will lead the neuropathy center at Saint Louis University, which has already been serving the Association’s community for many years.

The Neuropathy Center at Ohio State University
John T. Kissel, M.D., Co-Director
Victoria Lawson, M.D., Co-Director
Amy Bartlett, Center Coordinator
1654 Upham Drive, 4th Fl., Means Hall
Columbus, OH 43210
614-366-9050

The Neuropathy Center at Saint Louis University
Florian P. Thomas, M.D., M.A., Ph.D., Director
Sheila Boismenue, LPN, Center Coordinator
3660 Vista Avenue
St. Louis, MO 63110
314-977-6082

Peripheral Neuropathy HELP and SUPPORT:

http://www.neuropathy.org

The Neuropathy Association is the leading national non-profit organization serving the peripheral neuropathy community. We provide support and education, advocate for patients’ interests, and promote research into the causes of and cures for neuropathy.

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