WASHINGTON, July 22, 2019 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that on
July 19, 2019, it received a
notification from the U.S. Food and Drug Administration (FDA)
stating that as part of its ongoing review of Vanda's supplemental
New Drug Application (sNDA) for
HETLIOZ® (tasimelteon) for the treatment of Jet Lag
Disorder, the FDA has identified deficiencies that preclude
discussion of labeling and postmarketing requirements/commitments
at this time. No deficiencies were disclosed by the FDA in this
notification, and the FDA stated that this notification does not
reflect a final decision on the information under review. In a
letter dated December 19, 2018, the
FDA had assigned a Prescription Drug User Fee Act ("PDUFA") target
date for completion of its review by August
16, 2019.
Vanda has extensively studied the efficacy of the circadian
regulator Hetlioz® on Jet Lag Disorder (JLD), which
occurs following rapid eastward transmeridian travel and can result
in significant and impairing symptoms. The majority of eastward
transmeridian travelers will experience JLD. More than 30 million
Americans travel across five or more eastward time zones
annually.
Hetlioz® was shown to be well tolerated prior to
its first approval by the FDA in 2014. Since its commercial launch
in 2014, thousands of patients with Non-24-Hour Sleep-Wake Disorder
have been exposed to Hetlioz®, many for periods of
several years and on a daily basis.
In addition, Vanda has studied Hetlioz® for
almost 15 years in different settings and conditions, and
Hetlioz® has consistently demonstrated robust
biological effects and clinical benefits.
Vanda anticipates receiving additional communication from the
FDA identifying specific deficiencies in the sNDA. Vanda hopes that
it will be able to work expeditiously with the FDA to resolve any
such deficiencies.
About Vanda Pharmaceuticals Inc.
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.
Forward Looking Statements
Various statements in this release are "forward-looking
statements" under the securities laws. Forward-looking statements
are based upon current expectations that involve risks, changes in
circumstances, assumptions and uncertainties. Important factors
that could cause actual results to differ materially from those
reflected in the Company's forward-looking statements include the
Company's discussion and potential resolution of the deficiencies
that the FDA believes are contained in the sNDA and other factors
that are described in the "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" sections of the Company's annual report on Form 10-K
for the fiscal year ended December 31,
2018 and quarterly report on Form 10-Q for the quarter ended
March 31, 2019, which are on file
with the Securities and Exchange Commission (SEC) and available on
the SEC's website at www.sec.gov. Additional factors may be set
forth in those sections of the Company's quarterly report on Form
10-Q for the quarter ended June 30,
2019, to be filed in the third quarter of 2019. In addition
to the risks described above and in the Company's annual report on
Form 10-K and quarterly reports on Form 10-Q, other unknown or
unpredictable factors also could affect the Company's results.
There can be no assurance that the actual results or developments
anticipated by the Company will be realized or, even if
substantially realized, that they will have the expected
consequences to, or effects on, the Company. Therefore, no
assurance can be given that the outcomes stated in such
forward-looking statements and estimates will be achieved.
Investor Contact:
Jim
Kelly
Executive Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
Media Contacts:
AJ Jones II
Burson Cohn & Wolfe (BCW)
1110 Vermont Avenue, NW, Suite 1200
Washington, D.C. 20005
202-530-0400
pr@vandapharma.com
Elizabeth Van Every
Burson Cohn & Wolfe (BCW)
230 Park Avenue South
New York, NY 10003
212-614-3881
pr@vandapharma.com
SOURCE Vanda Pharmaceuticals Inc.
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SOURCE Vanda Pharmaceuticals Inc.