WASHINGTON, April 24, 2015 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that
the European Medicines Agency's (EMA) Committee for Medicinal
Products for Human Use (CHMP) has adopted a positive opinion
recommending approval of HETLIOZ® (tasimelteon)
for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in
totally blind adults in the European Union (EU).
"The positive opinion by CHMP on HETLIOZ® is
another milestone on the road to approval in the EU and the
building of a global brand to benefit patients with Non-24
throughout the world," said Mihael H.
Polymeropoulos, M.D., Vanda's President and CEO.
The CHMP positive opinion will be reviewed by the European
Commission (EC). If approved, the EC grants a centralized
marketing authorization with unified labeling that is valid in the
28 countries that are members of the EU, as well as European
Economic Area members Iceland,
Liechtenstein and Norway. The EC usually issues a final decision
within two months of a CHMP opinion.
In 2011, HETLIOZ® was granted orphan drug designation
for the treatment of Non-24 in blind people with no light
perception from the EC. HETLIOZ® was
approved by the U.S. Food and Drug Administration in January 2014 and is available through specialty
pharmacies in the U.S.
About the CHMP Positive Opinion for HETLIOZ® (from
EMA release)
Summary of opinion[1] (initial
authorisation)
On 23 April 2015, the Committee
for Medicinal Products for Human Use (CHMP) adopted a positive
opinion, recommending the granting of a marketing authorisation for
the medicinal product HETLIOZ®, intended for the
treatment of non-24-hour sleep-wake disorder in totally blind
adults. HETLIOZ® was designated as an orphan
medicinal product on 23 February
2011. The applicant for this medicinal product is Vanda
Pharmaceuticals Ltd.
HETLIOZ® will be available as 20 mg hard
capsules. The active substance of HETLIOZ® is
tasimelteon, a psycholeptic (ATC code: N05CH03). Tasimelteon is a
melatonin receptor agonist and acts as a circadian regulator that
resets the master body clock in the suprachiasmatic
nucleus.
The benefit with HETLIOZ® is its ability to
entrain the master body clock in patients with non-24-hour
sleep-wake disorder. The most common side effects are headache,
somnolence, and nightmares or unusual dreams.
The full indication is: "HETLIOZ® is indicated
for the treatment of non-24-hour sleep-wake disorder (non-24) in
totally blind adults".
Detailed recommendations for the use of this product will be
described in the summary of product characteristics (SmPC), which
will be published in the European public assessment report (EPAR)
and made available in all official European Union languages after
the marketing authorisation has been granted by the European
Commission.
(1) Summaries of positive opinion are published without
prejudice to the Commission decision, which will normally be issued
67 days from adoption of the opinion.
The announcement of the CHMP positive opinion for
HETLIOZ® can be found on the EMA website at
http://www.ema.europa.eu.
About Non-24-Hour Sleep-Wake Disorder
Non-24 was
first described more than 60 years ago, and is a chronic, circadian
rhythm disorder resulting from the misalignment of the endogenous
master body clock to the 24-hour day, disrupting the sleep-wake
cycle. The sleep disturbance causes significant distress or
impairment in social, occupational and other important areas of
functioning. Non-24 affects the majority of totally blind
individuals and it has been estimated that approximately 130,000
people in the European Union have the disorder.
About HETLIOZ®
HETLIOZ® is a melatonin receptor agonist.
HETLIOZ® has been approved by the U.S. Food and
Drug Administration for the treatment of Non-24. For full U.S.
prescribing information, please
visit www.hetlioz.com.
U.S. Indication and Important Safety Information About
HETLIOZ®
Indication
HETLIOZ® is indicated for the treatment of
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 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, 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.
Full U.S. HETLIOZ® Prescribing Information can be
found at: www.hetlioz.com.
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.
CAUTIONARY NOTE REGARDING 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 Vanda's forward-looking statements include, among
others, Vanda's assumptions regarding the regulatory status of
HETLIOZ® in the European Union 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 Vanda's annual report on Form 10-K for the
fiscal year ended December 31, 2014, which is on file with
the SEC and available on the SEC's website
at www.sec.gov. In addition to the risks described above and
in Vanda's annual report on Form 10-K and quarterly reports on Form
10-Q, other unknown or unpredictable factors also could affect
Vanda's results. There can be no assurance that the actual results
or developments anticipated by Vanda will be realized or, even if
substantially realized, that they will have the expected
consequences to, or effects on, Vanda. Therefore, no assurance can
be given that the outcomes stated in such forward
All written and verbal forward-looking statements attributable
to Vanda or any person acting on its behalf are expressly qualified
in their entirety by the cautionary statements contained or
referred to herein. Vanda cautions investors not to rely too
heavily on the forward-looking statements Vanda makes or that are
made on its behalf. The information in this release is
provided only as of the date of this release, and Vanda undertakes
no obligation, and specifically declines any obligation, to update
or revise publicly any forward-looking statements, whether as a
result of new information, future events or otherwise.
U.S. full prescribing information for HETLIOZ® is
available at www.HETLIOZ.com.
HETLIOZ® is a registered trademark of Vanda
Pharmaceuticals Inc.
Corporate Contact:
Jim Kelly
Senior Vice
President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
Media Contact:
Laney Landsman
Assistant
Vice President
Makovsky
(212) 508-9643
llandsman@makovsky.com
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SOURCE Vanda Pharmaceuticals Inc.