Vanda Pharmaceuticals Inc. (VANDA) (NASDAQ: VNDA) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tasimelteon, a circadian regulator. Vanda is seeking FDA approval of tasimelteon for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind. Tasimelteon was developed to address a significant unmet medical need, the treatment of Non-24, for which there are currently no FDA approved products.
Non-24 is a serious and rare, circadian rhythm disorder that affects the majority of totally blind individuals who lack light perception and who therefore cannot entrain (synchronize) their master body clock to the 24-hour day.
"The NDA submission of tasimelteon for Non-24 represents a significant accomplishment for Vanda in our efforts to address unmet medical needs," said Mihael H. Polymeropoulos M.D ., Vanda's President and Chief Executive Officer. "We are excited to have submitted an application for the first circadian regulator, representing a new class of therapeutics. The data demonstrates that tasimelteon is able to reset the master body clock and synchronize the melatonin and cortisol circadian rhythms, resulting in significant clinical benefits to patients".
Vanda previously announced that the FDA confirmed, at a recent pre-NDA meeting, that the efficacy, safety and supporting data package proposed to be included in the NDA would be adequate to support filing of the NDA for review by the Agency. The tasimelteon Non-24 NDA includes data from the largest clinical program conducted to date for any investigational therapy for the treatment of Non-24.
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