Prestwick Wins Approval for Huntington’s Drug
Prestwick Pharmaceuticals has announced that the FDA has approved Xenazine for the treatment of chorea associated with Huntington’s disease.
Xenazine is said to be the first and only FDA-approved treatment for any symptom of Huntington’s disease (HD) and is expected to be available later 2008.
A double-blind, placebo-controlled, Phase III study found that Xenazine significantly reduced patients’s chorea burden, improved global outcome scores, and was generally safe and well tolerated.
Xenazine will be marketed under an FDA-approved risk evaluation and mitigation strategy to decrease the risk of depression and suicidal ideation that may be associated with the drug, and are often pre-existing conditions in HD patients.
George Horner, III, president and CEO of Prestwick, said: “The approval of Xenazine is a huge advancement for the HD community, and we thank them for their contributions in helping to make this important product available in the US.”