- Dose proportionality and bioequivalence studies demonstrate
once-daily AUSTEDO XR is therapeutically equivalent to twice-daily
AUSTEDO® (deutetrabenazine) tablets
- The U.S. Food and Drug Administration (FDA) approved
once-daily AUSTEDO XR extended-release tablets on February 17,
2023
- AUSTEDO is the only vesicular monoamine transporter 2
(VMAT2) inhibitor approved for both tardive dyskinesia and chorea
associated with Huntington’s disease indications in adults with
3-year long-term data1,2
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced six poster
abstracts across its neurology portfolio will be presented at the
American Academy of Neurology (AAN) Annual Meeting on April 22-27,
2023. Abstracts include data for AUSTEDO (deutetrabenazine)
tablets, as well as once-daily AUSTEDO XR (deutetrabenazine)
extended-release tablets. AUSTEDO XR was recently approved by the
FDA, as a once-daily formulation of AUSTEDO for adults living with
tardive dyskinesia (TD) and chorea associated with Huntington’s
disease (HD), which can be taken with or without food. It is
expected to be commercially available later this year.
“Much of the data we’re presenting served as a foundation for
the FDA’s recent approval of AUSTEDO XR,” said Eric Hughes, MD,
PhD, Executive Vice President of R&D and Chief Medical Officer
at Teva. “We’re excited clinicians will have the opportunity to
better understand the potential of AUSTEDO XR as a once-daily
option that can deliver the same therapeutic benefit as twice-daily
AUSTEDO for adults living with TD and HD chorea.”
Notably, these presentations include new data from dose
proportionality and bioequivalence studies, which supported the FDA
approval of once-daily AUSTEDO XR extended-release tablets –
demonstrating AUSTEDO XR is therapeutically equivalent to the
currently marketed twice-daily AUSTEDO. Bioequivalence and relative
bioavailability were established between the once-daily and
twice-daily tablet formulations, with no new safety findings
emerging. Additionally, dose proportional exposures were achieved
for 6 mg, 12 mg and 24 mg deutetrabenazine dose strengths and
AUSTEDO XR may be used across the full clinical dose range (6 mg –
48 mg).
Teva will also present real-world data showing people living
with HD chorea who are taking antipsychotic medications with
twice-daily AUSTEDO experienced improved motor signs. Additional
abstracts from the Enroll-HD Global Registry and AJOVY®
(fremanezumab-vfrm) will also be presented.
This year’s annual AAN meeting is being offered both in person
and virtually. Abstracts can be accessed here.
The full set of data sponsored by Teva includes:
Poster Session 1: Sunday, April 23, 8:00 AM - 9:00 AM
ET
Enroll-HD Global Registry:
- (Encore) Chorea Severity Change Over Time in Huntington Disease
and by Huntington Disease Stage (P1.010)
- (De novo) The Risk of Depression in a Large Huntington Disease
Population Compared With Controls: Analysis of the Enroll-HD
Registry Data (P1.012)
Poster Session 2: Sunday April 23, 11:45 AM - 12:15 PM
ET
AUSTEDO XR:
- (De novo) A Bioequivalence Comparison at Steady State between
the Newly Developed Once-Daily Extended Release Tablet Formulation
and the Approved Twice-Daily Tablet Formulation of Deutetrabenazine
(P2.015)
- (De novo) Assessment of Dose Proportionality of Three Dose
Strengths (6 mg, 12 mg and 24 mg) over the Clinical Dose Range
(6-48 mg) of the Newly Developed Once-Daily Extended Release Tablet
Formulation of Deutetrabenazine (P2.016)
AUSTEDO:
- (Encore) Real-World Effectiveness and Safety of
Deutetrabenazine in Combination with Antipsychotic Drugs in
Patients With Chorea Associated With Huntington Disease
(P2.010)
Enroll-HD Global Registry:
- (Encore) Baseline Characteristics and Treatment Patterns of a
Global Huntington Disease Population Stratified by Chorea Severity
(P2.011)
Poster Session 10: Wednesday April 26, 8:00 AM – 9:00 AM
ET
AJOVY:
- (De novo): Initiation of Fremanezumab Earlier in the Treatment
Cycle may Result in Cost Savings to Payors in the United States
(P10.002)
Poster Session 12: Wednesday April 26, 5:30 PM – 6:30 PM
ET
AJOVY:
- (Encore) Effectiveness of Fremanezumab for the Preventive
Treatment of Migraine: Second Interim Analysis of the Observational
PEARL Study (P12.002)
- (De novo): No “Wearing-Off Effect” Seen with Fremanezumab in
the Real-World: Retrospective, Claims-Based Analysis of
Migraine-Related HealthCare Resource and Acute Medication Use
(P12.005)
Poster Session 13: Thursday, April 27, 8:00 AM – 9:00 AM
ET
AJOVY:
- (Encore) Real-World Effectiveness of Fremanezumab in Patients
with Migraine who Switched from another Mab Targeting the CGRP
Pathway (P13.007)
- (Encore) Fremanezumab for Migraine Prevention: Interim Analysis
of the Non-Interventional FINESSE Study (P13.010)
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.
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.
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. AUSTEDO
XR is the once-daily formulation of AUSTEDO. Safety and
effectiveness in pediatric patients have not been established.
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 AJOVY (fremanezumab-vfrm) injection
AJOVY is indicated for prophylaxis of migraine in adults who
have at least 4 migraine days per month. AJOVY is available as a
225 mg/1.5 mL single dose injection in a pre-filled syringe or, in
some countries, in a pre-filled pen. Two dosing options are
available: 225 mg once monthly administered as one subcutaneous
injection (monthly dosing), or 675 mg every three months (quarterly
dosing), which is administered as three subcutaneous
injections.
AJOVY can be administered either by a healthcare professional or
at home by a patient or caregiver. No starting dose is required to
begin treatment.
INDICATION AJOVY is indicated for the preventive
treatment of migraine in adults. Please see full Prescribing
Information for AJOVY.
IMPORTANT SAFETY INFORMATION
Contraindications: AJOVY is contraindicated in patients
with serious hypersensitivity to fremanezumab-vfrm or to any of the
excipients. Reactions have included anaphylaxis and angioedema.
Hypersensitivity Reactions: Hypersensitivity reactions,
including rash, pruritus, drug hypersensitivity, and urticaria were
reported with AJOVY in clinical trials. Most reactions were mild to
moderate, but some led to discontinuation or required
corticosteroid treatment. Most reactions were reported from within
hours to one month after administration. Cases of anaphylaxis and
angioedema have been reported in the postmarketing setting. If a
hypersensitivity reaction occurs, consider discontinuing AJOVY and
institute appropriate therapy.
Adverse Reactions: The most common adverse reactions in
clinical trials (≥5% and greater than placebo) were injection site
reactions.
Information for Europe about AJOVY can be found
here.
This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
events. Information can be found at https://www.hpra.ie.
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 medicines 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; the
development and commercial success of AJOVY; 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
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 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. 2 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.
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IR Contacts United States Ran Meir (267) 468-4475
Yael Ashman 972 (3) 914-8262
PR Contacts United States Doris Yiu (973) 265-3752
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