Vanda Announces Submission To FDA Of A New Drug Application For Tasimelteon
For The Treatment Of Non-24-Hour Disorder In The Totally Blind
WASHINGTON, May 31, 2013
WASHINGTON, May 31, 2013 /PRNewswire/ --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
"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.
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 the 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 have a master body clock that continually
delays, resulting in prolonged periods of misalignment between their
circadian rhythms and the 24-hour day-night cycle, including the timing of
melatonin and cortisol secretion and the sleep-wake cycle. As a result of
this misalignment, Non-24 is associated with significant impairments in social
and occupational functioning and marked subjective distress. For more
information on Non-24, please visit www.Non-24.com.
Tasimelteon is a circadian regulator in development for the treatment of
Non-24. Tasimelteon is a dual melatonin receptor agonist (DMRA) with
selective agonist activityat the MT1 and MT2 receptors.^ Tasimelteon's
ability to reset the master body clock in the suprachiasmatic nucleus (SCN)
results in the entrainment of the body's melatonin and cortisol rhythms with
the 24-hour day-night cycle. The patent claiming tasimelteon as a new
chemical entity extends through December 2022, assuming a 5-year extension to
be granted under the Hatch-Waxman Act.Tasimelteon has been granted orphan
drug designation for the treatment of Non-24 from both the U.S. and the
About Vanda Pharmaceuticals Inc.:
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the
development and commercialization of products for the treatment of central
nervous system disorders.For more on Vanda, please visit www.vandapharma.com.
Senior Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
Assistant Vice President
SOURCE Vanda Pharmaceuticals Inc.
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