WASHINGTON, Dec. 20, 2018 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that
the U.S. Food and Drug Administration (FDA) has accepted the filing
of Vanda's Supplemental New Drug Application for
HETLIOZ® (tasimelteon) for the treatment of
jet lag disorder.
The FDA determined the action target date under Prescription
Drug User Fee Act (PDUFA-VI), to be August
16, 2019.
HETLIOZ® is currently approved for the treatment
of Non-24 Hour Sleep Wake Disorder. For a review of the current
prescribing information of HETLIOZ® please
visit www.hetlioz.com.
About HETLIOZ® (tasimelteon)
HETLIOZ® (tasimelteon) is a melatonin receptor
agonist. HETLIOZ® has been granted market
authorization by the U.S. Food and Drug Administration and the
European Medicines Agency. For full U.S. prescribing information,
please visit www.hetlioz.com.
Important Safety Information
The most common adverse reactions (incidence >5% and at least
twice as high on HETLIOZ® (tasimelteon) than on
placebo) were headache, increased alanine aminotransferase,
nightmares or unusual dreams, and upper respiratory or urinary
tract infection. The risk of adverse reactions may be greater in
elderly (>65 years) patients than younger patients because
exposure to HETLIOZ® is increased by approximately
2-fold compared with younger patients.
Indication
HETLIOZ® is indicated for the treatment of
Non-24-Hour Sleep-Wake Disorder (Non-24).
Important Safety Information
HETLIOZ® may cause somnolence: After taking
HETLIOZ®, patients should limit their activity to
preparing for going to bed, because HETLIOZ® can
potentially impair the performance of activities requiring complete
mental alertness.
The most common adverse reactions (incidence >5% and at least
twice as high on HETLIOZ® than on placebo) were
headache, increased alanine aminotransferase, nightmares or unusual
dreams, and upper respiratory or urinary tract infection. The risk
of adverse reactions may be greater in elderly (>65 years)
patients than younger patients because exposure to
HETLIOZ® is increased by approximately 2-fold
compared with younger patients.
Use of HETLIOZ® should be avoided in combination
with fluvoxamine or other strong CYP1A2 inhibitors, because of a
potentially large increase in exposure of HETLIOZ®, and
a greater risk of adverse reactions.
HETLIOZ® should be avoided in combination with
rifampin or other CYP3A4 inducers, because of a potentially large
decrease in exposure of HETLIOZ®, with reduced
efficacy.
There are no adequate and well-controlled studies of
HETLIOZ® in pregnant women. Based on animal data,
HETLIOZ® may cause fetal harm.
HETLIOZ® should be used during pregnancy only if
the potential benefit justifies the potential risks. Caution should
be exercised when HETLIOZ® is administered to a
nursing woman.
HETLIOZ® has not been studied in patients with
severe hepatic impairment and is not recommended in these
patients.
Safety and effectiveness of HETLIOZ® in
pediatric patients have not been established.
About Vanda
Vanda is a global biopharmaceutical company focused on the
development and commercialization of innovative therapies to
address high unmet medical needs and improve the lives of patients.
For more on Vanda Pharmaceuticals Inc., please
visit www.vandapharma.com.
HETLIOZ® is Vanda's registered trademark. Any other
trademarks, registered marks and trade names and service marks
appearing in this release are the property of their respective
holders.
Corporate Contact:
Jim
Kelly
Executive Vice President and Chief Financial
Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.