FDA committee votes unanimously to approve tetrabenazine for Huntington's chorea

WASHINGTON An advisory committee to the Food and Drug Administration voted unanimously to recommend the approval of tetrabenazine, an investigational compound for the treatment of chorea associated with Huntington’s disease, according to published reports. This would be the first drug approved in the U.S. to treat chorea associated with Huntington’s disease.

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

“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, the company manufacturing the drug. “We are committed to continuing to work with the FDA to secure full approval of tetrabenazine.”

Tetrabenazine has been designated as an orphan drug by the FDA and has been granted fast track status.