Findings evaluate safety, quality of life and
patient-centered outcome measures up to 145 weeks
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced new data
from the 3-year open-label extension study of AUSTEDO®
(deutetrabenazine) Tablets that studied patients with tardive
dyskinesia (TD) will be presented at the 2021 American Psychiatric
Association (APA) Virtual Annual Meeting, being held online from
May 1-3.
The new data includes three abstracts that examine the long-term
safety, quality of life (QoL) and patient-centered outcome measures
of patients living with TD who were treated with AUSTEDO up to 145
weeks following two pivotal 12-week studies (ARM-TD and
AIM-TD).
“TD is a serious movement disorder and we continue to evaluate
AUSTEDO to determine its therapeutic potential following the
pivotal clinical trials,” said Denisa Hurtukova, MD, VP, Head of
North America Medical Affairs. “The data being presented at APA
give healthcare providers valuable insights into safety and certain
aspects of quality of life among TD patients, which could have an
important impact on treatment considerations and ultimately the
wellbeing of patients.”
In an analysis of the long-term safety of AUSTEDO, 337 patients
with 723 patient-years of exposure were evaluated, all of whom had
completed ARM-TD or AIM-TD. AUSTEDO was administered using a
response-driven dosing regimen, titrating up to a maximum total
daily dose of 48 mg/day based on dyskinesia control and
tolerability. Safety measures included incidence of any adverse
events (AEs), serious adverse events (SAEs) and AEs leading to
withdrawal, dose reduction or dose suspension, as well as the most
common AEs (≥4 percent). Since differences in incidence rates may
be related to different durations of observation, exposure-adjusted
incidence rates (EAIRs) were used to calculate AE frequencies. 269
(79.8 percent) patients reported ≥1 AE and AEs considered by the
investigator to be treatment related were reported in 154 (45.7
percent) patients. Low EAIRs were reported for most AEs, including
1.22 for any AE, 0.09 for SAEs, 0.34 for treatment-related AEs,
0.06 for AEs leading to withdrawal, 0.05 for AEs leading to dose
suspension, and 0.09 for AEs leading to dose reduction. The most
common AEs (EAIRs) were anxiety (0.06), depression (0.05),
somnolence (0.05), weight decreased (0.05) and urinary tract
infection (0.05).
- Poster 4807: Long-Term Safety of Deutetrabenazine in Patients
with Tardive Dyskinesia: Results from the Completed, 3-year
Open-Label Extension Study
The OLE also investigated AUSTEDO in relation to patients’ QoL
using the Modified Craniocervical Dystonia Questionnaire (mCDQ-24)
score, a disease-specific QoL questionnaire adjusted to focus on
the impact of TD. Patients’ QoL was evaluated based on the mean
change +/- SE from baseline in the mCDQ-24 total score and the
stigma, pain, activities of daily living (ADL), emotional and
social subdomain scores through week 106. Of the 337 analyzed,
changes in mean mCDQ-24 total scores from baseline were observed at
week 6 (-3.2 +/- 0.68) and sustained through week 106 (-5.2 +/-
1.11). Treatment resulted in clinically meaningful improvements
based on changes as measured by the mCDQ-24 total score and the
stigma, pain, ADL, emotional and social subdomain scores.
- Poster 4849: Long-Term Deutetrabenazine Treatment is Associated
with Sustained Improvements in Quality of Life in Patients with
Tardive Dyskinesia
Finally, the OLE also evaluated patient-centric outcomes,
including the percentage of patients to achieve treatment success
(defined as “much improved” or “very improved”) on the Patient
Global Impression of Change (PGIC), change from baseline in the
patient-reported modified mCDQ-24 score and changes from baseline
in the Abnormal Involuntary Movement Scale (AIMS) items 8, 9, 10,
which are clinician-rated global judgments of the overall severity
of abnormal movements, the incapacitation due to abnormal
movements, and the patient’s awareness of abnormal movements,
respectively. The analysis found more than half of the patients
achieved PGIC treatment success at week 6, and the proportion
increased over time from 54 percent at weeks 6 and 15, to 61
percent at week 54, 64 percent at week 106 and 63 percent at week
145. According to the mCDQ-24 score, patients demonstrated
improvement in QoL at week 6 (mean change +/- SE from baseline:
-3.2 +/- 0.68) that continued throughout the study (week 15, -5.0
+/- 0.70; week 54, -5.0 +/- 0.89; week 106, -5.2 +/- 1.11).
Patients also experienced improvements from baseline in AIMS items
8, 9 and 10, which were sustained through week 145 (mean change +/-
SE: -1.3 +/- 0.07 for item 8; -1.3 +/- 0.08 for item 9, and -1.3
+/- 0.09 for item 10).
- Poster 4390: Improvements in Patient-Centered Outcome Measures
with Long-Term Deutetrabenazine Treatment Among Patients with
Tardive Dyskinesia
Posters are available online and can be accessed via the APA
meeting website at: www.psychiatry.org/annualmeeting.
AUSTEDO® Indications and Usage
AUSTEDO® is indicated for the treatment of chorea associated
with Huntington’s disease and for the treatment of tardive
dyskinesia in adults.
Important Safety Information About AUSTEDO®
Depression and Suicidality in Patients with Huntington’s
Disease: 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® is contraindicated in patients who are suicidal,
and in patients with untreated or inadequately treated
depression.
Contraindications: AUSTEDO® is contraindicated in
patients with Huntington’s disease who are suicidal, or have
untreated or inadequately treated depression. AUSTEDO® is 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 (Xenazine®) or valbenazine (Ingrezza®).
Clinical Worsening and Adverse Events in Patients with
Huntington’s Disease: AUSTEDO® may cause a worsening in
mood, cognition, rigidity, and functional capacity.
Prescribers should periodically re-evaluate the need for
AUSTEDO® in their patients by assessing the effect on chorea
and possible adverse effects.
QTc Prolongation: AUSTEDO may prolong the QT interval,
but the degree of QT prolongation is not clinically significant
when AUSTEDO is administered within the recommended dosage range.
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®;
intensive symptomatic treatment and medical monitoring; and
treatment of any concomitant serious medical problems.
Akathisia, Agitation, and Restlessness: 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® dose should be reduced; some patients may require
discontinuation of therapy.
Parkinsonism: 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® dose should be reduced; some patients may require
discontinuation of therapy.
Sedation and Somnolence: Sedation is a common
dose-limiting adverse reaction of 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® 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®.
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.
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 specialty 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 specialty 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
regarding AUSTEDO, 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:
- the commercial success of AUSTEDO;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; consolidation of our customer base and commercial
alliances among our customers; delays in launches of new generic
products; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; our ability to develop
and commercialize biopharmaceutical products; competition for our
specialty products, 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, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- our business and operations in general, including: uncertainty
regarding the COVID-19 pandemic and its impact on our business,
financial condition, operations, cash flows, and liquidity and on
the economy in general; our ability to successfully execute and
maintain the activities and efforts related to the measures we have
taken or may take in response to the COVID-19 pandemic and
associated costs therewith; effectiveness of our optimization
efforts; our ability to attract, hire and retain highly skilled
personnel; manufacturing or quality control problems; interruptions
in our supply chain; disruptions of information technology systems;
breaches of our data security; variations in intellectual property
laws; challenges associated with conducting business globally,
including political or economic instability, major hostilities or
terrorism; costs and delays resulting from the extensive
pharmaceutical regulation to which we are subject or delays in
governmental processing time due to travel and work restrictions
caused by the COVID-19 pandemic; the effects of reforms in
healthcare regulation and reductions in pharmaceutical pricing,
reimbursement and coverage; significant sales to a limited number
of customers; our ability to successfully bid for suitable
acquisition targets or licensing opportunities, or to consummate
and integrate acquisitions; and our prospects and opportunities for
growth if we sell assets;
- compliance, regulatory and litigation matters, including:
failure to comply with complex legal and regulatory environments;
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications and our ability to
reach a final resolution of the remaining opioid-related
litigation; scrutiny from competition and pricing authorities
around the world, including our ability to successfully defend
against the U.S. Department of Justice criminal charges of Sherman
Act violations; potential liability for patent infringement;
product liability claims; failure to comply with complex Medicare
and Medicaid reporting and payment obligations; compliance with
anti-corruption sanctions and trade control laws; and environmental
risks;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities (including as a result of
potential tax reform in the United States); and the effect on our
overall effective tax rate of the termination or expiration of
governmental programs or tax benefits, or of a change in our
business;
and other factors discussed in this press release and in our
Quarterly Report on Form 10-Q for the first quarter of 2021 and in
our Annual Report on Form 10-K for the year ended December 31,
2020, including in the sections captioned "Risk Factors” and
“Forward Looking Statements.” 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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