Data support overnight conversion from
tetrabenazine to AUSTEDO™ for the treatment of chorea associated
with Huntington disease
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and the
Huntington Study Group today announced results from the Phase III
open-label, single-arm switch cohort of the ARC-HD
(Alternatives for Reducing Chorea in
HD) study were published in JAMA Neurology. Results from the
study showed patients with chorea associated with Huntington
disease (HD) were able to safely switch overnight from three times
daily tetrabenazine to twice daily AUSTEDO™ (deutetrabenazine)
tablets. The ARC-HD study was conducted by Teva in partnership with
the Huntington Study Group.
A rare and fatal neurodegenerative disorder, HD affects
approximately 35,000 people in the United States. Chorea –
involuntary, random and sudden, twisting and/or writhing movements
– is one of the most striking physical manifestations of this
disease and occurs in approximately 90% of patients. HD may also
manifest as cognitive deterioration and behavioral and/or
psychological problems.
“Chorea is a debilitating symptom of Huntington disease that can
impact the safety, function and quality of life of many patients,”
said Michael Hayden, M.D., Ph.D., President of Global R&D and
Chief Scientific Officer at Teva. “We are pleased to share the
ARC-HD study results to allow those physicians treating HD patients
to increase their knowledge of AUSTEDO™.”
“Human-based research is critical to evolving our understanding
of HD and to providing more options and meaningful treatments,”
said Samuel Frank, M.D., principal investigator of the ARC-HD study
and Director of the Huntington’s Disease Society of America Center
of Excellence at Beth Israel Deaconess Medical Center. “It could
not be done without the dedication of patients and their families
who participate in clinical trials, for which we are extremely
grateful.”
The ARC-HD study enrolled 37 patients who had been on a stable
tetrabenazine regimen (≥8 weeks). Patients were converted from
tetrabenazine to an initial AUSTEDO™ daily dose of approximately
half the prior tetrabenazine daily dosage. One week after overnight
conversion to AUSTEDO™, investigators could begin weekly dose
adjustments, if needed, to achieve optimal chorea control. Changes
from baseline in United Huntington’s Disease Rating Scale (UHDRS),
Total Maximal Chorea Score (TMC) and Total Motor Score (TMS) were
evaluated as efficacy endpoints.
For more information regarding this JAMA Neurology publication,
visit
http://jamanetwork.com/journals/jamaneurology/fullarticle/2643174.
About AUSTEDO™
Austedo™ is an oral, small molecule inhibitor of vesicular
monoamine 2 transporter, or VMAT2, that is designed to regulate the
levels of neurotransmitters in the brain. Austedo™ is approved in
the United States for the treatment of chorea associated with
Huntington’s disease.
Important Safety Information
WARNING: DEPRESSION AND
SUICIDALITY. AUSTEDOTM can increase the
risk of depression and suicidal thoughts and behavior (suicidality)
in patients with Huntington’s disease. Anyone considering the use
of AUSTEDOTM must balance the risks of
depression and suicidality with the clinical need for treatment of
chorea. AUSTEDOTM is contraindicated in patients
who are suicidal, and in patients with untreated or inadequately
treated depression.
AUSTEDOTM is also contraindicated in: patients with hepatic
impairment; patients taking monoamine oxidase inhibitors (MAOIs),
or within 14 days of discontinuing MAOI therapy; patients taking
reserpine or within 20 days of discontinuing reserpine; and
patients taking tetrabenazine (XENAZINE®). VMAT2 inhibitors,
including AUSTEDOTM, may cause a worsening in mood, cognition,
rigidity, and functional capacity. Neuroleptic Malignant
Syndrome has been observed in patients receiving tetrabenazine (a
closely related VMAT2 inhibitor). AUSTEDOTM may increase the
risk of akathisia, agitation, and restlessness and may cause
parkinsonism in patients with Huntington’s disease. Sedation is a
common dose-limiting adverse reaction of AUSTEDOTM.
Tetrabenazine causes an increase in the corrected QT (QTc)
interval. A clinically relevant QT prolongation may occur in some
patients treated with AUSTEDOTM who are CYP2D6 poor
metabolizers or are co-administered a strong CYP2D6 inhibitor.
Tetrabenazine elevates serum prolactin concentrations in
humans.
Since deutetrabenazine or its metabolites bind to
melanin-containing tissues, it could accumulate in these tissues
over time. The most common adverse reactions (>8% of
AUSTEDOTM-treated patients and greater than placebo) in a
controlled clinical study were: somnolence, diarrhea, dry mouth,
and fatigue. Please click here for full Prescribing Information,
including Boxed Warning: austedo.com/pi. A copy may be
requested from the US Medical Information Contact Center for
Teva Specialty Medicines at 888-4-TEVA-RX (888-483-8279)
and USMedInfo@tevapharm.com or Teva’s Public
Relations or Investor Relations contacts.
About Huntington Disease
Huntington disease (HD) is a fatal neurodegenerative disease
characterized by uncoordinated and uncontrollable movements,
cognitive deterioration and behavioral and/or psychological
problems. Onset of HD symptoms typically occurs in middle age, but
the disease also manifests in children and the elderly. HD is the
most common genetic cause of abnormal involuntary writhing
movements called chorea.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by approximately 200
million patients in 100 markets every day. Headquartered in Israel,
Teva is the world’s largest generic medicines producer, leveraging
its portfolio of more than 1,800 molecules to produce a wide range
of generic products in nearly every therapeutic area. In specialty
medicines, Teva has the world-leading innovative treatment for
multiple sclerosis as well as late-stage development programs for
other disorders of the central nervous system, including movement
disorders, migraine, pain and neurodegenerative conditions, as well
as a broad portfolio of respiratory products. Teva is leveraging
its generics and specialty capabilities in order to seek new ways
of addressing unmet patient needs by combining drug development
with devices, services and technologies. Teva's net revenues in
2016 were $21.9 billion. For more information, visit
www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding deutetrabenazine, which are based on management’s current
beliefs and expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such
differences include risks relating to:
- challenges inherent in product research
and development, including uncertainty of clinical success and
obtaining regulatory approvals;
- our specialty medicines business,
including: competition for our specialty products, especially
Copaxone®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; our ability to achieve expected
results from investments in our product pipeline; competition from
companies with greater resources and capabilities; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our business and operations in general,
including: our ability to develop and commercialize additional
pharmaceutical products; manufacturing or quality control problems,
which may damage our reputation for quality production and require
costly remediation; interruptions in our supply chain; disruptions
of our or third party information technology systems or breaches of
our data security; the restructuring of our manufacturing network,
including potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; and variations in
patent laws that may adversely affect our ability to manufacture
our products;
- compliance, regulatory and litigation
matters, including: costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; product liability claims; increased government scrutiny
of our patent settlement agreements; failure to comply with
complex Medicare and Medicaid reporting and payment
obligations; and environmental risks;
and other factors discussed in our Annual Report on Form 20-F
for the year ended December 31, 2016 (“Annual Report”),
including in the section captioned “Risk Factors,” and in our other
filings with the U.S. Securities and Exchange Commission,
which are available at www.sec.gov and www.tevapharm.com.
Forward-looking statements speak only as of the date on which they
are made, and we assume no obligation to update or revise any
forward-looking statements or other information contained herein,
whether as a result of new information, future events or otherwise.
You are cautioned not to put undue reliance on these
forward-looking statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20170711005650/en/
Teva Pharmaceutical Industries Ltd.IR
Contacts:United StatesKevin C. Mannix,
215-591-8912Ran Meir, 215-591-3033orIsraelTomer
Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley, 215-591-8974Nancy
Leone, 215-284-0213
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