FDA recommends Hetlioz (Vanda) for Non-24 Hour Disorder

The FDA Peripheral and Central Nervous System Drugs Advisory Committee voted overwhelmingly to recommend the approval of Vanda's New Drug Application for tasimelteon, proposed tradename Hetlioz, for the treatment of Non-24-Hour Disorder (Non-24) in the totally Blind. There are currently no approved treatments for Non-24 Disorder and the FDA granted the drug a priority review in July.

Phase III trials reported in June achieved the primary endpoints of entrainment of the melatonin (aMT6s) rhythm as compared to placebo and clinical response as measured by entrainment plus a score of greater than or equal to 3 on the Non-24 Clinical Response Scale (N24CRS). Tasimelteon also demonstrated significant improvement versus placebo across a number of sleep and wake parameters including measures of total sleep time, nap duration, and timing of sleep, as well as in the Clinical Global Impression of Change (CGI-C), an overall global functioning scale.