Xenazine finds smooth sailing
FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously last week to recommend the use of Prestwick Pharmaceuticals Inc.'s Xenazine tetrabenazine to treat chorea associated with Huntington's disease, despite concerns about the lack of a patient-rated measure of benefit, unimpressive gains in secondary efficacy endpoints and the drug's adverse events profile.
Indeed, the committee spent little time discussing whether Xenazine should be approved and more time inquiring about the finer points of study design and how Xenazine might be prescribed in clinical practice.
In the first of two questions up for vote, the agency asked the panel to consider whether the non-significant results for most secondary efficacy endpoints raised sufficient concerns about the utility of Xenazine to justify non-approval. In the second question, the panel was asked to consider whether Xenazine's adverse events profile presented sufficient risk to justify non-approval.
In the U.S., there are no approved products to treat chorea, the most common and debilitating symptom experienced by >90% of HD patients at some stage of the disease. Chorea is a hyperkinetic movement disorder characterized by involuntary continuous, abrupt, rapid and irregular movements that flow randomly throughout the body. Chorea