New once-daily option for the treatment of
adults with tardive dyskinesia (TD) and chorea associated with
Huntington’s disease (HD) is available in 6 mg, 12 mg, and 24 mg
tablet strengths and can be taken with or without food
- Once-daily AUSTEDO XR has been shown to be therapeutically
equivalent to twice-daily AUSTEDO, providing another effective
treatment choice for TD and HD chorea patients1
- In the longest TD clinical trial to date, twice-daily
AUSTEDO demonstrated rapid TD symptom control as early as 2 weeks
with sustained results observed through 3 years.1-5 Once-daily
AUSTEDO XR contains the same active ingredient as twice-daily
AUSTEDO
- Teva Shared Solutions® helps patients get started on AUSTEDO
XR by navigating insurance, identifying financial assistance
options and providing ongoing nurse adherence support
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced that
once-daily AUSTEDO XR (deutetrabenazine) extended-release tablets
are now available for adults in the United States in 6 mg, 12 mg
and 24 mg tablet strengths. AUSTEDO XR was recently approved by the
U.S. Food and Drug Administration (FDA) for adults living with
tardive dyskinesia (TD) and chorea associated with Huntington’s
disease (HD). AUSTEDO is the only vesicular monoamine transporter 2
(VMAT2) inhibitor with 3-year data that is indicated in adults for
both TD and HD chorea indications.5,6
"We're pleased to now make available a once-daily formulation
for the many TD and HD chorea patients and caregivers who have
requested that Teva provide this option,” said Sven Dethlefs, PhD,
Executive Vice President, North America Commercial at Teva. “The
twice-daily formulation will also remain available so that patients
may have a choice for what works best for them. Teva will continue
to work closely with the community to ensure patients and their
healthcare providers are able to easily access this important
medication.”
Since 2017, Teva has been supporting patients and their families
with TD and HD chorea and their prescribers by providing an
effective treatment option for their uncontrollable movements.
Once-daily AUSTEDO XR has been shown to be therapeutically
equivalent to the twice-daily formulation – offering a new and
effective treatment choice.1 AUSTEDO XR may also result in a
decreased pill count for patients compared to the twice-daily
AUSTEDO. AUSTEDO XR and AUSTEDO are the only VMAT2 inhibitor TD
treatments with no restrictions for use alongside CYP3A4/5
inducers.7,8
The Wholesale Acquisition Cost (WAC or “list price”) for AUSTEDO
XR ranges from $2,360.25 - $7,080.70 for a 30-day supply depending
on dosage strength. Actual costs for individual patients are
anticipated to be lower than WAC because WAC does not account for
additional rebates and discounts that may apply. Approximately 90%
of patients with insurance coverage are expected to pay $10 or less
with financial assistance offerings.1 Teva is committed to helping
patients who have been prescribed AUSTEDO XR access their
medication. Teva continues to support with access, reimbursement,
prescription pull-through and patient assistance. Savings on
out-of-pocket costs may vary depending on the patient’s insurance
provider and eligibility for participation in the co-pay assistance
program. For more information regarding cost and coverage options
for AUSTEDO XR through Teva Shared Solutions, visit
MySharedSolutions.com.
About Tardive Dyskinesia (TD) Tardive dyskinesia (TD) is
a highly debilitating, chronic movement disorder that affects one
in four people who take certain mental health treatments and is
characterized by uncontrollable, abnormal, and repetitive movements
of the face, torso, and/or other body parts, which may be
disruptive and negatively impact individuals.9-11
About Chorea Associated with Huntington’s Disease (HD)
Huntington’s Disease (HD) is a fatal neurodegenerative disease
characterized by uncoordinated and uncontrollable movements,
cognitive deterioration and behavioral and/or psychological
problems.12 Chorea – involuntary, random and sudden, twisting
and/or writhing movements – is one of the most striking physical
manifestations of Huntington’s disease and occurs in approximately
90% of patients.12,13 Chorea can have a significant impact on daily
activities and progressively limit peoples’ lives.12
About AUSTEDO XR Extended-Release Tablets and AUSTEDO
Tablets AUSTEDO is the first and only vesicular monoamine
transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug
Administration in adults for the treatment of tardive dyskinesia
and for the treatment of chorea associated with Huntington’s
disease. Safety and effectiveness in pediatric patients have not
been established. AUSTEDO XR is the once-daily formulation of
AUSTEDO.
INDICATIONS AND USAGE AUSTEDO® XR (deutetrabenazine)
extended-release tablets and AUSTEDO® (deutetrabenazine) tablets
are indicated in adults for the treatment of chorea associated with
Huntington’s disease and for the treatment of tardive
dyskinesia.
IMPORTANT SAFETY INFORMATION
Depression and Suicidality in Patients with Huntington’s
Disease: AUSTEDO XR and AUSTEDO can increase the risk of
depression and suicidal thoughts and behavior (suicidality) in
patients with Huntington’s disease. Balance the risks of depression
and suicidality with the clinical need for treatment of chorea.
Closely monitor patients for the emergence or worsening of
depression, suicidality, or unusual changes in behavior. Inform
patients, their caregivers, and families of the risk of depression
and suicidality and instruct them to report behaviors of concern
promptly to the treating physician. Exercise caution when treating
patients with a history of depression or prior suicide attempts or
ideation. AUSTEDO XR and AUSTEDO are contraindicated in patients
who are suicidal, and in patients with untreated or inadequately
treated depression.
Contraindications: AUSTEDO XR and AUSTEDO are
contraindicated in patients with Huntington’s disease who are
suicidal, or have untreated or inadequately treated depression.
AUSTEDO XR and AUSTEDO are also contraindicated in: patients with
hepatic impairment; patients taking reserpine or within 20 days of
discontinuing reserpine; patients taking monoamine oxidase
inhibitors (MAOIs), or within 14 days of discontinuing MAOI
therapy; and patients taking tetrabenazine or valbenazine.
Clinical Worsening and Adverse Events in Patients with
Huntington’s Disease: AUSTEDO XR and AUSTEDO may cause a
worsening in mood, cognition, rigidity, and functional
capacity. Prescribers should periodically re-evaluate the
need for AUSTEDO XR or AUSTEDO in their patients by assessing the
effect on chorea and possible adverse effects.
QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the
QT interval, but the degree of QT prolongation is not clinically
significant when AUSTEDO XR or AUSTEDO is administered within the
recommended dosage range. AUSTEDO XR and AUSTEDO should be avoided
in patients with congenital long QT syndrome and in patients with a
history of cardiac arrhythmias.
Neuroleptic Malignant Syndrome (NMS), a potentially fatal
symptom complex reported in association with drugs that reduce
dopaminergic transmission, has been observed in patients receiving
tetrabenazine. The risk may be increased by concomitant use of
dopamine antagonists or antipsychotics. The management of NMS
should include immediate discontinuation of AUSTEDO XR and AUSTEDO;
intensive symptomatic treatment and medical monitoring; and
treatment of any concomitant serious medical problems.
Akathisia, Agitation, and Restlessness: AUSTEDO XR and
AUSTEDO may increase the risk of akathisia, agitation, and
restlessness. The risk of akathisia may be increased by concomitant
use of dopamine antagonists or antipsychotics. If a patient
develops akathisia, the AUSTEDO XR or AUSTEDO dose should be
reduced; some patients may require discontinuation of therapy.
Parkinsonism: AUSTEDO XR and AUSTEDO may cause
parkinsonism in patients with Huntington’s disease or tardive
dyskinesia. Parkinsonism has also been observed with other VMAT2
inhibitors. The risk of parkinsonism may be increased by
concomitant use of dopamine antagonists or antipsychotics. If a
patient develops parkinsonism, the AUSTEDO XR or AUSTEDO dose
should be reduced; some patients may require discontinuation of
therapy.
Sedation and Somnolence: Sedation is a common
dose-limiting adverse reaction of AUSTEDO XR and AUSTEDO. Patients
should not perform activities requiring mental alertness, such as
operating a motor vehicle or hazardous machinery, until they are on
a maintenance dose of AUSTEDO XR or AUSTEDO and know how the drug
affects them. Concomitant use of alcohol or other sedating drugs
may have additive effects and worsen sedation and somnolence.
Hyperprolactinemia: Tetrabenazine elevates serum
prolactin concentrations in humans. If there is a clinical
suspicion of symptomatic hyperprolactinemia, appropriate laboratory
testing should be done and consideration should be given to
discontinuation of AUSTEDO XR and AUSTEDO.
Binding to Melanin-Containing Tissues: Deutetrabenazine
or its metabolites bind to melanin-containing tissues and could
accumulate in these tissues over time. Prescribers should be aware
of the possibility of long-term ophthalmologic effects.
Common Adverse Reactions: The most common adverse
reactions for AUSTEDO (>8% and greater than placebo) in a
controlled clinical study in patients with Huntington’s disease
were somnolence, diarrhea, dry mouth, and fatigue. The most common
adverse reactions for AUSTEDO (4% and greater than placebo) in
controlled clinical studies in patients with tardive dyskinesia
were nasopharyngitis and insomnia. Adverse reactions with AUSTEDO
XR extended-release tablets are expected to be similar to AUSTEDO
tablets.
Please see accompanying full Prescribing Information, including
Boxed Warning.
About Teva Teva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) has been developing and producing medicines to improve
people’s lives for more than a century. We are a global leader in
generic and innovative medicines with a portfolio consisting of
over 3,500 products in nearly every therapeutic area. Around 200
million people around the world take a Teva medicine every day, and
are served by one of the largest and most complex supply chains in
the pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of innovative and
biopharmaceutical products. Learn more at 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,
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. You can identify these
forward-looking statements by the use of words such as “should,”
“expect,” “anticipate,” “estimate,” “target,” “may,” “project,”
“guidance,” “intend,” “plan,” “believe” and other words and terms
of similar meaning and expression in connection with any discussion
of future operating or financial performance. Important factors
that could cause or contribute to such differences include risks
relating to the development and commercial success of AUSTEDO
(deutetrabenazine) tablets and AUSTEDO XR (deutetrabenazine)
extended-release tablets; our ability to successfully compete in
the marketplace, including our ability to develop and commercialize
biopharmaceutical products, competition for our innovative
medicines, including AUSTEDO, AJOVY® and COPAXONE®, our ability to
achieve expected results from investments in our product pipeline,
our ability to develop and commercialize additional pharmaceutical
products, and the effectiveness of our patents and other measures
to protect our intellectual property rights; our substantial
indebtedness; our business and operations in general, including,
the impact of global economic conditions and other macroeconomic
developments and the governmental and societal responses thereto,
and costs and delays resulting from the extensive pharmaceutical
regulation to which we are subject; compliance, regulatory and
litigation matters, including failure to comply with complex legal
and regulatory environments; other financial and economic risks;
and other factors discussed in our Quarterly Report on Form 10-Q
for the first quarter of 2023 and in our Annual Report on Form 10-K
for the year ended December 31, 2022, including in the section
captioned “Risk Factors.” 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.
_____________________________
1 Data on file. Parsippany, NJ: Teva Neuroscience, Inc. 2
Anderson K. E., Stamler D., Davis M. D., et al. Deutetrabenazine
for the treatment of involuntary movements in patients with tardive
dyskinesia (AIM-TD): a double-blind, randomized,
placebo-controlled, phase 3 trial. Lancet Psychiatry.
2017;4(8):595-604 3 Fernandez HH, Factor SA, Hauser RA, et al.
Randomised controlled trial of deutetrabenazine for tardive
dyskinesia: the ARM-TD study. Neurology. 2017;88(21):2003-2010. 4
Marder S. R., Singer C., Lindenmayer J-P., et al. A phase 3,
1-year, open-label trial of valbenazine in adults with tardive
dyskinesia. J Clin Psychopharmacol. 2019;39(6)620-627. 5 Hauser, R.
A., Barkay, H., Fernandez, H. H. et al. Long-Term Deutetrabenazine
Treatment for Tardive Dyskinesia is Associated with Sustained
Benefits and Safety: A 3-Year, Open-Label Extension Study.
Frontiers in Neurology (2022).
https://doi.org/10.3389/fneur.2022.773999. 6 Frank, S., Testa, C.,
Edmondson, M.C. et al. The Safety of Deutetrabenazine for Chorea in
Huntington Disease: An Open-Label Extension Study. CNS Drugs
(2022). https://doi.org/10.1007/s40263-022-00956-8. 7 AUSTEDO® XR
(deutetrabenazine) extended-release tablets and AUSTEDO®
(deutetrabenazine) tablets [current approved prescribing
information].Parsippany, NJ: Teva Neuroscience, Inc 8 AUSTEDO®
(deutetrabenazine) tablets current Prescribing Information.
Parsippany, NJ: Teva Neuroscience, Inc. 9 Warikoo N, Schwartz T,
Citrome L. Tardive dyskinesia. In: Schwartz TL, Megna J, Topel ME,
eds. Antipsychotic Drugs. Hauppauge, NY: Nova Science Publishers.
2013:235-258. 10 Waln O, Jankovic J. An Update on Tardive
Dyskinesia: From Phenomenology to Treatment. Tremor Other
Hyperkinet Mov. 2013;3:1-11. 11 Tardive dyskinesia. National
Alliance on Mental Illness website.
https://www.nami.org/Learn-More/Treatment/Mental-Health-Medications/Tardive-Dyskinesia.
Accessed May 15, 2023. 12 Huntington’s Disease. National Institute
of Neurological Disorders and Stroke.
https://www.ninds.nih.gov/health-information/disorders/huntingtons-disease#toc-what-is-huntington-s-disease-.
Accessed May 15, 2023. 13 Thorley, E. M., Iyer, R. G., Wicks, P.,
Curran, C., Gandhi, S. K., Abler, V., Anderson, K. E., &
Carlozzi, N. E. (2018). Understanding How Chorea Affects
Health-Related Quality of Life in Huntington Disease: An Online
Survey of Patients and Caregivers in the United States. The
patient, 11(5), 547–559.
https://doi.org/10.1007/s40271-018-0312-x
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