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FDA Advisory Committee Recommends Approval of Vanda Pharmaceuticals Inc's HETLIOZ for Treatment of Non-24-Hour-Disorder (Non-24) in Totally Blind


Thursday, 14 Nov 2013 10:56pm EST 

Vanda Pharmaceuticals Inc announced 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 the safety of tasimelteon in Non-24 has been adequately addressed. 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 the safety of tasimelteon in Non-24 has been adequately addressed. The FDA grants Priority Review status for a "drug that treats a serious condition and, if approved, would provide 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. 

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