- 92% of patients with Huntington's disease (HD) chorea
achieved optimal dosing by week 12 with treatment on the AUSTEDO
4-week patient titration kit according to early results from the
START study
- Additional results further reinforce the efficacy and
tolerability of AUSTEDO from an analysis of safety and efficacy
data across approved vesicular monoamine transporter 2 (VMAT2)
inhibitors
- AUSTEDO remains the only VMAT2 inhibitor with 3-year data
for this progressive condition1,2
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced new HD data
will be presented at the Huntington Study Group® (HSG) Annual
Meeting on November 2-4 in Phoenix, AZ.
“Through our discussions with the HD community, we understand
the importance of providing treatment options that are not only
safe and effective but set patients up for success by ensuring
treatment regimens are manageable and tolerable,” said Eric Hughes,
MD, PhD, Executive Vice President of Global R&D and Chief
Medical Officer at Teva. “Knowing the unique challenges that this
neurodegenerative condition can pose, we’re excited to share this
latest data with the scientific community, further supporting that
AUSTEDO is an effective treatment option for patients with HD
chorea.”
Interim results from the 17 patients enrolled in the HD cohort
of the START trial, a Phase 4 study investigating real-world
utilization of AUSTEDO with a 4-week patient titration kit along
with treatment success as measured at the end of treatment, show
that by week 12:
- 50% of patients achieved treatment success as assessed by the
Clinical Global Impression of Change (CGIC) and 63% as assessed by
the Patient Global Impression of Change (PGIC)
- 41% mean reduction in total maximal chorea (TMC) score from
baseline
- 92% of patients achieved a maintenance dose of ≥24 mg/day
- 71% of patients successfully completed the titration kit, with
adherence averaging 91%
- 100% of patients who completed the satisfaction survey found
the kit easy to use
“With 90% of HD patients developing chorea,3,4 it’s critical
that treatment options can address the unmet needs of this
community,” said Karen Anderson, MD, Professor, Psychiatry and
Neurology at Georgetown University School of Medicine and Director,
Huntington’s Disease Care, Education and Research Center. “These
data reinforce that in real-world settings the AUSTEDO 4-week
Patient Titration Kit enabled patients to titrate to therapeutic
AUSTEDO doses with satisfaction, adherence, and effectiveness
similar to results demonstrated in the pivotal clinical
trials.”
Two additional posters will be presented at the HSG Annual
Meeting. The first shares results of a chart review of seven
patients who discontinued tetrabenazine because of ineffectiveness
and then started treatment on AUSTEDO. TMC scores mostly improved
with AUSTEDO treatment, and the safety profile was consistent with
AUSTEDO’s known safety profile.
The second shows an analysis of the number needed to treat (NNT)
and number needed to harm (NNH) for all three FDA-approved VMAT2
inhibitors. NNTs for treatment success based on CGIC and PGIC
ranged from 3-4 and 4-5, respectively, for the VMAT2 inhibitors.
Significant NNHs included:
- For deutetrabenazine: Diarrhea
- For valbenazine: Somnolence, lethargy, sedation, urticaria and
rash
- For tetrabenazine: Somnolence, insomnia, depression, akathisia,
anxiety/anxiety aggravated, balance difficulty and
parkinsonism/bradykinesia
Together, the data provide additional insight into the
real-world efficacy and safety of AUSTEDO for patients with HD
chorea.
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.3 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.3,4 Chorea can have a significant impact on daily
activities and progressively limit peoples’ lives.3
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) 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 and
AUSTEDO XR; our ability to successfully compete in the marketplace,
including our ability to develop and commercialize competition for
our innovative medicines, our ability to achieve expected results
from investments in our product pipeline, our ability to develop
and commercialize additional pharmaceutical products, our ability
to successfully launch and execute our new 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 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 second 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.
______________________
- 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.
- 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.
- 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.
- 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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version on businesswire.com: https://www.businesswire.com/news/home/20231102180929/en/
IR Ran Meir, +1 (267) 468-4475 Yael Ashman, +972 (3) 914
8262 Sanjeev Sharma, +1 (973) 658 2700
PR Kelley Dougherty, +1 (973) 832-2810 Eden Klein, +972
(3) 906 2645
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