Vanda Says FDA Advisory Committee Recommends Approval Of HETLIOZ

(RTTNews) - Vanda Pharmaceuticals Inc. (VNDA), said that the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration, voted to recommend the approval of the NDA for tasimelteon, which carries the trade name HETLIOZ, for the treatment of Non-24-Hour Disorder in the totally blind. Currently, there is no approved treatment for Non-24, the company said.

The panel found that the clinical endpoints of tasimelteon are suitable to support the Non-24 indication, which is appropriate for an FDA-approved therapy. Along with that, the panel concluded the safety and efficacy of tasimelteon has been proved with necessary evidence.

Vanda's tasimelteon NDA is currently under Priority Review by the FDA, with an action target date under the Prescription Drug User Fee Act (PDUFA-V) of January 31, 2014.