Tetrabenazine - FDA Review - December 6, 2007 - ACT NOW!

Dear Friends,

YOUR HELP IS NEEDED URGENTLY!!

The opportunity has finally arrived to make your voices heard in support of tetrabenazine for use with chorea associated with Huntington's disease!

The FDA has asked the Peripheral and Central Nervous System (PCNS) Advisory Committee, a group of outside experts, to review tetrabenazine. While the FDA has acknowledged that tetrabenazine seems to work, they are questioning whether it is safe for patients and whether the risks outweigh the benefits.

During the PCNS advisory committee meeting on December 6, 2007, Prestwick Pharmaceuticals will present information to the FDA regarding tetrabenazine. There will also be an open session from 1-2pm in which the advisory committee and the FDA will listen to testimony from the public. This is the Huntington's disease community's opportunity to make our feelings known!

During the public session, I plan to speak about my experience with Huntington's disease and why I believe tetrabenazine can offer Huntington's disease patients a desperately needed treatment for their chorea. Patients in clinical trials as well as patients in other countries where it is approved have had success in treating their chorea. There are currently no approved treatments in the United States for chorea associated with Huntington's disease. We need the PCNS panel of experts to advise the FDA to approve tetrabenazine as a safe and effective treatment for chorea associated with Huntington's disease. Huntington's patients, in consultation with their families and healthcare providers, should be able to have the option to try tetrabenazine and see if it works for them.

As we all know, chorea is not simply a cosmetic issue. Chorea is incredibly incapacitating for patients and is a major cause of morbidity and mortality for people suffering from Huntington's. The panelists that will be advising the FDA need to hear from you about your experience with chorea associated with Huntington's disease.

YOU CAN MAKE A DIFFERENCE!

You can speak at the open hearing during the advisory committee, which will take place from 1-2pm on December 6, 2007 in Beltsville, MD (just outside of Washington, DC). We need patients suffering from chorea to speak to the potential for this much needed use of tetrabenazine. We would like to have as many people come as possible to show your support!

To speak at the open hearing during the PCNS advisory committee meeting, please email the following information by November 7 to Darrell Lyons (Darrell.lyons@fda.hhs.gov):

• A brief statement of what you would like to present
• Your name and address
• How long you would like to speak

Detail of the meeting:
Date: December 6, 2007
Place: Sheraton College Park Hotel - The Ballroom
4095 Powder Mill Road
Beltsville, Maryland
Time: 8am-5pm (ET)
1-2pm (ET) - Open Session to hear testimony from the public

If you would prefer to provide a written statement to the panel of experts, you can submit your statement to Darrell Lyons (Darrell.lyons@fda.hhs.gov) by November 21.

It is important that youÑthe caretaker, family member or patientÑconvey to the committee either in person or in your letter:

• how devastating chorea is for you or for your relatives who have Huntington's disease;
• why you would want the option to try a new treatment like tetrabenazine;
• how tetrabenazine has helped your chorea; and/or
• how important it is to have the FDA Committee recommend approval of tetrabenazine.

If you plan to speak at the hearing, please let us know so we can help coordinate with all the speakers. Please contact me at wexlern@pi.cpmc.columbia or 212.543.5667.

With many thanks,

Nancy S. Wexler, Ph.D.
President, Hereditary Disease Foundation

Higgins Professor of Neuropsychology Columbia University

View 2006 Press Release