FDA Advisory Committee Voted Unanimously to Recommend Approval of Tetrabenazine for Chorea Associated with Huntington's Disease in December 2006, Yet There STILL is No Approved Treatment

On December 6, 2007, an advisory committee to the U.S. Food and Drug Administration (FDA) voted unanimously to recommend the approval of tetrabenazine. More than five months have passed and patients still have no FDA approved treatment for their chorea or involuntary movements, a condition that affects 90% of Huntington's disease patients. Tetrabenazine could be the first drug approved in the United States to treat chorea associated with Huntington’s disease and the first FDA-approved treatment for any aspect of Huntington's disease. Tetrabenazine has been used safely in Europe, Canada and Australia for over four decades.

We need your help to encourage the FDA to approve tetrabenazine now because patients cannot wait any longer for a treatment for their chorea.

To encourage the FDA to approve tetrabenazine now, please write the FDA. You can use the template below to write the FDA, modify it if you would like or write your own version. You can mail your letter, fax or email it to:

Andrew Von Eschenbach
Food and Drug Administration
5600 Fishers Lane
Parklawn Building, Room 14-7 1
Rockville, MD 20857
andrew.voneschenbach@fda.hhs.gov
301-443-3100 (fax)

CC: Janet Woodcock, Gerald Dal Pan, Henry Francis

 

SAMPLE LETTER:

Dear Dr. Von Eschenbach,

We need tetrabenazine to be approved now! On December 6, 2007 an FDA advisory committee unanimously recommended tetrabenazine be approved and now 5 months later, tetrabenazine still has not been approved. Why has there been such a delay in approving this safe and effective drug for a serious condition that affects 90% of the Huntington's disease patient population? We need tetrabenazine approved now.

Please help!

Sincerely,

 

 

FDA Advisory Committee Votes Unanimously to Recommend Approval of Tetrabenazine for Chorea Associated with Huntington's Disease

Thu Dec 6, 2007 5:46pm EST

WASHINGTON, Dec. 6 /PRNewswire/ -- An advisory committee to the U.S. Food and Drug Administration (FDA) today voted unanimously to recommend the approval of tetrabenazine, which would be the first drug approved in the United States to treat chorea associated with Huntington disease (HD).

“The advisory committee's support of tetrabenazine represents an important advancement for Huntington disease patients, caregivers, advocates and physicians who treat this devastating disease,” said George F. Horner III, president and chief executive officer of Prestwick. “We are committed to continuing to work with the FDA to secure full approval of tetrabenazine.”

While the FDA is not required to follow the advice of its advisory committees, they generally do.

HD is a devastating neurodegenerative disease that causes progressive movement disorders, cognitive dysfunction and behavioral changes, that is ultimately a fatal condition. Chorea is characterized by excessive, involuntary and repetitive movements which are the most visible and dangerous manifestations of Huntington disease.

“Patients and physicians do not have any approved treatments to alleviate this disorder or any aspect of Huntington disease,” said Frederick Marshall, MD, chief of the geriatric neurology unit at the University of Rochester, who presented data on behalf of Prestwick. “We are hopeful that the FDA will adhere to the recommendations made by the committee to quickly bring tetrabenazine to the patients for whom we care.”

Chorea affects over 30,000 Americans, interfering with their ability to perform activities of daily living, including dressing, bathing and caring for themselves. Currently, there are no treatments to stop or reverse the onset or progression of HD and there are no FDA-approved drugs for chorea.

About Tetrabenazine

Tetrabenazine is an investigational compound for the treatment of chorea associated with HD. A highly selective and reversible centrally-acting dopamine depleting drug, tetrabenazine works by inhibiting a molecule known as VMAT2 (vesicular monoamine transporter 2).

Adverse events reported with tetrabenazine, most of which were addressed by titrating down the dose, included depression, akathisia, parkinsonism and sedation. Tetrabenazine’s effects are largely reversible and manageable.

The FDA has issued an approvable letter for the compound. Tetrabenazine has been designated as an “orphan drug” by the FDA and has been granted “fast track” status.

About Prestwick

Prestwick Pharmaceuticals, a privately-held pharmaceutical company headquartered in Washington, is currently managing a portfolio of pipeline product candidates being studied for CNS conditions with significant unmet needs, including Huntington's disease, Parkinson's disease, restless legs syndrome, schizophrenia, autism, Alzheimer's disease and sleep apnea. For more information, go to www.prestwickpharma.com

SOURCE Prestwick Pharmaceuticals
Jessica Carlso
+1-312-515-0501
jcarlson@wcpglobal.com
for Prestwick Pharmaceuticals
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