- U.S. FDA approves new one pill, once-daily AUSTEDO XR
tablets (30, 36, 42, 48 mg/day)
- AUSTEDO XR offers more flexibility with the most once-daily
doses of any vesicular monoamine transporter 2 (VMAT2) inhibitor
for effective and tolerable tardive dyskinesia (TD) and
Huntington’s disease (HD) chorea control1
- Patients with TD taking AUSTEDO XR can expect symptom
improvement as early as two weeks while patients with HD chorea may
experience a significant reduction in Total Maximal Chorea (TMC)
score, with three years of the longest TD and HD chorea clinical
trials and sustained results to date
1,2,3,4,5
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced that the
U.S. Food and Drug Administration (FDA) has approved AUSTEDO XR as
a one pill, once-daily treatment option, now with four new tablet
strengths (30, 36, 42, 48 mg) indicated in adults for TD and HD
chorea.
“Since our launch of AUSTEDO® in 2017, we have been committed to
helping people living with TD and HD chorea treat these chronic,
involuntary movements,” said Dell Faulkingham, Senior Vice
President, Head of U.S. Innovative Medicines at Teva. “AUSTEDO,
backed by the longest efficacy and tolerability data to date, has
continued to evolve – having received approval for AUSTEDO XR, our
once-daily extended-release formulation in February 2023. This
latest milestone offers a streamlined treatment regimen for
clinically therapeutic doses with the broadest dosing
flexibility.”
Currently more than 57 million Americans are living with a
mental illness, 14 million of whom are living with a serious mental
health condition.6 For those taking certain mental health
medications, one in four may experience the onset of TD, an
often-overlooked chronic movement disorder that can have a
physical, emotional and psychological impact on patients.7,8 HD is
a fatal neurodegenerative disease characterized by cognitive
deterioration, behavior and/or psychological problems and
uncoordinated and uncontrollable movements known as chorea – a
symptom that affects 90% of patients.9,10 Both conditions can pose
significant challenges to patients’ everyday lives as simple tasks
like eating, talking and walking can be impacted.
“Knowing patients living with TD and HD chorea are also managing
other underlying concomitant conditions, it is important that
treatment options for these chronic movement disorders are not only
effective, but keep the patient experience in mind,” said Dr.
Rakesh Jain, Clinical Professor of Psychiatry, Texas Tech
University School of Medicine. “This latest AUSTEDO XR approval
provides patients with the same proven efficacy, but now with the
convenience of a one pill, once-daily option for clinically
therapeutic doses as established by the pivotal clinical trials to
help control involuntary movements that can make carrying out basic
daily activities difficult."
Patients with TD taking AUSTEDO XR can expect symptom
improvement as early as two weeks while patients with HD chorea may
experience a significant reduction in TMC score, with three years
of the longest TD and HD chorea clinical trials and sustained
results to date.1,2,3,4,5 AUSTEDO XR, along with its twice-daily
counterpart, AUSTEDO (deutetrabenazine), are the only VMAT2
inhibitor treatments with no restrictions for use with CYP3A4/5
inducers or inhibitors, an important consideration for patients who
take a variety of concomitant medications to manage their
underlying conditions.11,12
Approximately 90% of patients with insurance coverage are
expected to pay $10 or less for their prescription with financial
assistance offerings.1 Teva is committed to helping eligible
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. 13,14,15
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. 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. Chorea can have a significant impact on daily
activities and progressively limit peoples’ lives. 9,10
About AUSTEDO XR Extended-Release Tablets and AUSTEDO
Tablets AUSTEDO XR and AUSTEDO are the first vesicular
monoamine transporter 2 (VMAT2) inhibitors 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) is a global pharmaceutical leader with a
category-defying portfolio, harnessing our generics expertise and
stepping up innovation to continue the momentum behind the
discovery, delivery, and expanded development of modern medicine.
For over 120 years, Teva's commitment to bettering health has never
wavered. Today, the company’s global network of capabilities
enables its ~37,000 employees across 58 markets to push the
boundaries of scientific innovation and deliver quality medicines
to help improve health outcomes of millions of patients every day.
To learn more about how Teva is all in for better health, 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,
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: our ability to successfully develop and commercialize
AUSTEDO and AUSTEDO XR for the treatment of tardive dyskinesia and
for the treatment of chorea associated with Huntington’s disease;
our ability to successfully compete in the marketplace, including
our ability to develop and commercialize additional pharmaceutical
products; our ability to successfully execute our Pivot to Growth
strategy, including to expand our innovative and biosimilar
medicines pipeline and profitably commercialize the innovative
medicines and biosimilar portfolio, whether organically or through
business development, and to sustain and focus our portfolio of
generics medicines; and other factors discussed in our Quarterly
Report on Form 10-Q for the first quarter of 2024 and in our Annual
Report on Form 10-K for the year ended December 31, 2023, 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 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. 3 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 4 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. 5 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. 6 U.S. Department of Health and
Human Services. (n.d.). Mental illness. National Institute of
Mental Health.
https://www.nimh.nih.gov/health/statistics/mental-illness. 7 Carbon
M, Hsieh CH, Kane JM, Correll CU. Tardive dyskinesia prevalence in
the period of second-generation antipsychotic use: a meta-analysis.
J Clin Psychiatry. 2017;78(3):e264-e278. 8 Hansen TE, Brown WL,
Weigel RM, Casey DE. Underrecognition of tardive dyskinesia and
drug-induced parkinsonism by psychiatric residents. Gen Hosp
Psychiatry. 1992;14(5):340-344. 9 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. 10 Thorley, E. M., Iyer, R. G., Wicks, P.,
Curran, C., Gandhi, S. K., Abler, V., Anderson, K. E., &
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11 AUSTEDO® XR (deutetrabenazine) extended-release tablets and
AUSTEDO® (deutetrabenazine) tablets [current approved prescribing
information].Parsippany, NJ: Teva Neuroscience, Inc 12 AUSTEDO®
(deutetrabenazine) tablets current Prescribing Information.
Parsippany, NJ: Teva Neuroscience, Inc. 13 Warikoo N, Schwartz T,
Citrome L. Tardive dyskinesia. In: Schwartz TL, Megna J, Topel ME,
eds. Antipsychotic Drugs. Hauppauge, NY: Nova Science Publishers.
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Accessed May 15, 2023.
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PR Contacts Kelley Dougherty +1 (973) 832-2810 Eden Klein
+972 (3) 906 2645 IR Contacts Yael Ashman +972 (3) 914 8262
Sanjeev Sharma +1 (973) 658 2700 Ran Meir +1 (267) 468-4475
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