An FDA advisory committee unanimously voted for the approval of Prestwick Pharmaceuticals' therapy related to Huntington's. Tetrabenazine is indicated for the treatment of chorea characterized by excessive, involuntary and repetitive movements, which are the most visible and dangerous manifestations of the disease.
Prestwick says that if FDA approval goes through, tetrabenazine will be the first drug in the U.S. to treat this indication. “We are committed to continuing to work with the FDA to secure full approval of tetrabenazine,” says George F. Horner III, president and CEO.
Tetrabenazine is a highly selective and reversible, centrally acting, dopamine-depleting drug and works by inhibiting a molecule known as VMAT2. It has been designated as an orphan drug and has been granted fast track status.