Vanda Pharmaceuticals Announces FDA Advisory Committee Meeting On November 14, 2013
Vanda Pharmaceuticals Inc. (VANDA) (NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has notified the company of the scheduling of a Peripheral and Central Nervous System Drugs Advisory Committee meeting on November 14, 2013, for the review of Vanda's New Drug Application (NDA) for tasimelteon, proposed trade name HETLIOZ™, for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind. 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.
About Non-24-Hour DisorderNon-24 is a serious, rare, and chronic circadian rhythm disorder characterized by the inability to entrain (synchronize) the master body clock with the 24-hour day-night cycle. Non-24 affects a majority of totally blind individuals, or between 65,000 and 95,000 people in the U.S. Non-24 occurs almost entirely in individuals who lack the light sensitivity necessary to entrain the master body clock in the brain with the 24-hour day-night cycle. Most people have a master body clock that naturally runs longer than 24-hours and light is the primary environmental cue that resets it to 24 hours each day. Individuals with Non-24