A U.S. Food and Drug Administration advisory committee voted unanimously to recommend approval of tetrabenzine for chorea associated with Huntington disease (HD). If approved it would be the first drug in the U.S. approved for the treatment of chorea. The FDA is not required to follow the suggestions of its advisory committees, however, approval usually follows such a recommendation.
"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."
Huntington disease is a neurodegenerative disease that causes progressive movement disorders, cognitive disfunction and behavioral changes and is ultimately a fatal condition. Chorea is the excessive, involuntary and repetitive movements which are the most visible and dangerous manifestations of the 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."
[Source: PrNewsWire]
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