European Medicines Agency Accepts HETLIOZ™ (tasimelteon) Marketing
Authorization Application for Non-24-Hour Sleep-Wake Disorder in the Totally
WASHINGTON, June 3, 2014
WASHINGTON, June 3, 2014 /PRNewswire/ --Vanda Pharmaceuticals Inc. (Vanda)
(NASDAQ: VNDA) announced today that its Marketing Authorization Application
(MAA) for oral HETLIOZ™ (tasimelteon) capsules has been accepted for
evaluation by the European Medicines Agency (EMA) for the treatment of
Non-24-Hour Sleep-Wake Disorder (Non-24).
"The EMA submission is an important milestone towards providing a treatment
option for people living with Non-24 in the European Union," said Mihael H.
Polymeropoulos, M.D., Vanda's President and CEO. "This continues our efforts
to expand the availability of HETLIOZ to markets outside the U.S."
HETLIOZ™ has been granted orphan drug designation for the treatment of Non-24
in blind people with no light perception from the European Commission.
HETLIOZ™ was approved by the FDA in January 2014 and is available through
specialty pharmacies in the U.S.
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 is estimated that approximately 130,000
people in the European Union have the disorder.
HETLIOZ™ is a melatonin receptor agonist. HETLIOZ™ has been approved by the
U.S. Food and Drug Administration for the treatment of Non-24-Hour Sleep-Wake
Disorder (Non-24). For full U.S. prescribing information, please
U.S. Indication and Important Safety Information About HETLIOZ™
HETLIOZ™ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder
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
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
Full HETLIOZ™ Prescribing Information can be found at: www.hetlioz.com.
AboutVanda 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: the regulatory status of tasimelteon in Europe, the prevalence
of Non-24 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 endedDecember 31, 2013 and quarterly report on Form
10-Q for the quarter ended March 31, 2014, which are 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-looking statements and estimates will be achieved.
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
HETLIOZ™ is a registered trademark of Vanda Pharmaceuticals Inc.
Senior Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
Assistant Vice President
SOURCE Vanda Pharmaceuticals Inc.
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