FDA Advisory Committee votes in favor of Vanda's tasimelteon NDA for Non-24-Hour Disorder

Nov 15 2013

Vanda Pharmaceuticals Inc. (VANDA) (NASDAQ: VNDA) announced today that the U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (Advisory Committee) voted overwhelmingly to recommend the approval of Vanda's New Drug Application (NDA) for tasimelteon, proposed tradename HETLIOZ™, for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind. 

The advisory panel found that:

• Non-24 is an appropriate indication for an FDA-approved therapy;
• the clinical endpoints are appropriate to support the indication;
• there is substantial evidence of tasimelteon efficacy in Non-24; and
• and the safety of tasimelteon in Non-24 has been adequately addressed.

"We are extremely pleased that the FDA's advisory committee has recommended that the FDA approve HETLIOZ™ for the treatment of Non-24 in the totally blind," said Mihael H. Polymeropoulos M.D., Vanda's President and Chief Executive Officer. "We are now one step closer toward our goal of providing a treatment option that addresses the physiologic cause of this serious, debilitating orphan condition that impacts a majority of totally blind individuals."

Vanda's tasimelteon NDA is currently under Priority Review by the FDA for the treatment of Non-24 in the totally blind, with an action target date under the Prescription Drug User Fee Act (PDUFA-V) of January 31, 2014.  

The FDA grants Priority Review status for a "drug that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness" over current therapies. Currently, there is no approved treatment for Non-24 and HETLIOZ™ has the potential to address this unmet medical need.

SOURCE Vanda Pharmaceuticals Inc.