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FDA Accepts Tasimelteon New Drug Application For Priority Review In The Treatment Of Non-24-Hour Disorder In The Totally Blind
Date:7/29/2013

WASHINGTON, July 29, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (VANDA) (NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing and granted a priority review classification to Vanda's New Drug Application (NDA) for tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind.

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[1].  Currently, there is no approved treatment for Non-24 and tasimelteon has the potential to address this unmet medical need.

"We are extremely pleased that the FDA has granted tasimelteon priority review for the treatment of Non-24 in the totally blind," said Mihael H. Polymeropoulos M.D., Vanda's President and Chief Executive Officer.  "The agency's acceptance of the NDA and decision to place tasimelteon in a category of expedited review are important milestones for Vanda as we take another step toward our goal of providing patients with a treatment for Non-24."

The FDA determined the action target date under Prescription Drug User Fee Act (PDUFA-V), to be January 31, 2014.  The FDA has also tentatively scheduled an advisory committee meeting to discuss the tasimelteon application on November 14, 2013.

About Non-24-Hour Disorder
Non-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 ne
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SOURCE Vanda Pharmaceuticals Inc.
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4. Vanda Presents Data From Phase III Studies that Demonstrate Tasimelteon Restores Daily Cortisol Rhythm In Blind Patients With Non-24-Hour Disorder
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