23 abstracts
appeared in the 2020 American Academy of Neurology (AAN) Science
Highlights Supplement
Teva Pharmaceuticals USA, Inc., an affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that new data for AJOVY® (fremanezumab-vfrm) injection
and AUSTEDO® (deutetrabenazine) tablets have appeared in an online
supplement to Neurology. The data includes 23 abstracts that
highlight a diverse set of data evaluating the efficacy and safety
of AJOVY and AUSTEDO.
The abstracts were originally planned for presentation at the
recently cancelled 2020 American Academy of Neurology (AAN) annual
meeting. In addition to the online supplement, the abstracts are
also available through the AAN online abstracts website.
“We are pleased to have an opportunity to share this important
data with the neurology community which build upon our
understanding of the efficacy and safety of AJOVY and AUSTEDO
across various patient populations, and further demonstrate Teva’s
commitment to the CNS space,” said Denisa Hurtukova, MD, VP, Head
of North America Medical Affairs. “Teva is committed to ongoing
evaluation of these significant therapies to help physicians,
healthcare providers and most importantly, patients, make informed
decisions about their treatments.”
The featured abstracts include new AJOVY and AUSTEDO data,
including results from an open-label extension of the FOCUS study,
a Phase IIIb study that evaluated the efficacy and safety of
quarterly and monthly treatment with AJOVY compared to placebo in
adult patients with migraine and documented inadequate response to
2-4 classes of prior preventive treatments. Another analysis using
the FDA Adverse Events Reporting System (FAERS) provides patient
and healthcare professional insight into the real-world experience
with CGRP pathway-targeted therapies. In addition, new data is
available from a long-term, open-label extension study which
examined the safety of AUSTEDO at higher doses beyond the approved
maximum dose to treat chorea associated with Huntington’s disease,
as well as the long-term experience with AUSTEDO in both younger
and older patients with tardive dyskinesia.
The full list of Teva abstracts in the Neurology supplement
includes:
AUSTEDO® (deutetrabenazine) Tablets:
De Novo:
- Evaluation of the Safety of Deutetrabenazine at Higher Doses to
Treat Chorea in Huntington's Disease
- Long-term Safety and Efficacy of Deutetrabenazine in Younger
and Older Patients with Tardive Dyskinesia
Encore:
- Minimal Clinically Important Difference in AIMS Score Based on
Clinical and Patient Global Impression of Change in Patients With
Tardive Dyskinesia Treated With Deutetrabenazine
- Effect of Deutetrabenazine on Metabolic Parameters in the
Treatment of Tardive Dyskinesia
AJOVY® (fremanezumab-vfrm) Injection:
De Novo:
- Impact of Fremanezumab on Headache-related Disability in
Patients With Migraine and Documented Inadequate Response to 2-4
Classes of Migraine Preventive Medication Classes in the Open–label
Extension of the Phase 3b FOCUS Study
- Efficacy and Safety of Fremanezumab in Patients With Episodic
and Chronic Migraine and Documented Inadequate Response to 2-4
Classes of Migraine Preventive Medications During the Open-label
Period of the Phase 3b FOCUS Study
- Safety and Tolerability of Fremanezumab in Patients With
Episodic and Chronic Migraine and Documented Inadequate Response to
2-4 Classes of Migraine Preventive Medications: Results From the
Open-label Period of the Phase 3b FOCUS Study
- Clinically Meaningful Responses to Fremanezumab in Patients
With Migraine and Documented Inadequate Response to 2–4 Migraine
Preventive Medication Classes in the Open–label Period of the
International, Multicenter Phase 3b FOCUS Study
- Impact of Fremanezumab on Migraine-associated Symptoms in
Patients With Episodic and Chronic Migraine and Documented
Inadequate Response to 2-4 Classes of Migraine Preventive
Medications During the Open-label Period of the Phase 3b FOCUS
Study
- Safety and Tolerability of Fremanezumab in Patients With
Episodic and Chronic Migraine: a Pooled Analysis of Phase 3
Studies
- Adverse Event Profiles of Therapies that Target the Calcitonin
Gene-Related Peptide (CGRP) Pathway, During the First Six Months
After Launch: A Real-World Data Analysis Using the FDA Adverse
Events Reporting System (FAERS)
- Cardiovascular Safety of Fremanezumab in Patients With Episodic
and Chronic Migraine: a Pooled Analysis of Phase 3 Studies
- Assessment of the Patient Experience Across All Phases of
Migraine
Encore:
- Efficacy with Fremanezumab in Migraine Patients with Comorbid
Moderate to Severe Depression and Documented Inadequate Response to
2-4 Classes of Migraine Preventive Treatments: Subgroup Analysis of
the Randomized, Placebo-Controlled FOCUS Study
- Early Onset of Response to Fremanezumab in Migraine Patients
with Moderate to Severe Depression and Documented Inadequate
Response to 2-4 Classes of Migraine Preventive Treatments: Subgroup
Analysis of the Randomized, Placebo-Controlled FOCUS Study
- Efficacy of Fremanezumab in Migraine Patients with Medication
Overuse and Documented Inadequate Response to 2-4 Migraine
Preventive Medication Classes: Subgroup Analysis of the Randomized,
Placebo-Controlled FOCUS Study
- Clinically Meaningful Responses to Fremanezumab in Migraine
Patients with Medication Overuse and Documented Inadequate Response
to 2-4 Migraine Preventive Medications in the Randomized,
Placebo-Controlled FOCUS Study
- Efficacy of Fremanezumab in Male Patients with Migraine and
Documented Inadequate Response to 2-4 Classes of Migraine
Preventive Medication Classes: Results of the Randomized,
Placebo-Controlled FOCUS Study
- Very Early Onset of Action of Fremanezumab in Patients with
Migraine and Documented Inadequate Response to 2-4 Classes of
Migraine Preventive Medications: Results of the International,
Multicenter, Randomized, Placebo-Controlled FOCUS Study
- Early Onset of Efficacy with Fremanezumab in Patients with
Medication Overuse and Documented Inadequate Response to 2-4
Classes of Migraine Preventive Treatments: Subgroup Analysis of the
Randomized, Double-Blind FOCUS Study
- Patient Preference for Dosing Regimen and Perception of Dosing
Flexibility with Fremanezumab for Migraine: Results From a Patient
Survey Following Completion of a 1-Year Extension Study
- Burden of Comorbid Depression and Anxiety on Migraine-Specific
Health-Related Quality of Life in Adult Migraine Patients in the
United States
- 10-Year Cost-Effectiveness Analyses of Fremanezumab Compared to
Erenumab as Preventive Treatment in Episodic Migraine for Patients
with Inadequate Response to Prior Preventive Treatments
About AJOVY® (fremanezumab-vfrm) injection
AJOVY is available as a 225 mg/1.5 mL single dose injection in a
prefilled syringe with two dosing options – 225 mg monthly
administered as one subcutaneous injection, or 675 mg every three
months (quarterly), which is administered as three subcutaneous
injections. AJOVY can be administered in office by a healthcare
professional or at home by a patient or caregiver. No starting dose
is required to begin treatment. The AJOVY autoinjector has been
approved by the FDA and is available in the U.S. In addition to the
U.S., the AJOVY autoinjector is currently available in Germany and
should soon be available in other select European markets.
U.S. Important Safety Information about AJOVY®
(fremanezumab-vfrm) injection
Contraindications: AJOVY is contraindicated in patients
with serious hypersensitivity to fremanezumab-vfrm or to any of the
excipients.
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. If a hypersensitivity
reaction occurs, consider discontinuing AJOVY and institute
appropriate therapy.
Adverse Reactions: The most common adverse reactions (≥5%
and greater than placebo) were injection site reactions.
Please click here for full U.S. Prescribing Information for
AJOVY® (fremanezumab-vfrm) injection.
About AUSTEDO® (deutetrabenazine)
AUSTEDO® is a vesicular monoamine transporter 2 (VMAT2)
inhibitor approved by the U.S. Food and Drug Administration for the
treatment of tardive dyskinesia in adults and for the treatment of
chorea associated with Huntington’s disease. Safety and
effectiveness in pediatric patients have not been established.
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: Tetrabenazine, a closely related VMAT2
inhibitor, causes an increase in the corrected QT (QTc) interval. A
clinically relevant QT prolongation may occur in some patients
treated with AUSTEDO® who are CYP2D6 poor metabolizers or are
co-administered a strong CYP2D6 inhibitor. Dose reduction may be
necessary. The use of AUSTEDO® in combination with other drugs
known to prolong QTc may result in clinically significant QT
prolongations. For patients requiring AUSTEDO® doses greater than
24 mg per day who are using AUSTEDO® with other drugs known to
prolong QTc, assess the QTc interval before and after increasing
the dose of AUSTEDO® or the other drugs. 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.
CYP2D6 Metabolism: In patients who are poor CYP2D6
metabolizers or are taking strong CYP2D6 inhibitors, the total
daily dosage of AUSTEDO® should not exceed 36 mg (maximum single
dose of 18 mg).
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 AJOVY® and 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 AJOVY and AUSTEO;
- our ability to successfully compete in the marketplace;
consolidation of our customer base and commercial alliances among
our customers; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; competition for our
specialty products, especially COPAXONE®, our leading medicine,
which faces competition from existing and potential additional
generic versions, competing glatiramer acetate products and
orally-administered alternatives; competition from companies with
greater resources and capabilities; delays in launches of new
products and our ability to achieve expected results from
investments in our product pipeline; ability to develop and
commercialize biopharmaceutical products; efforts of pharmaceutical
companies to limit the use of generics, including through
legislation and regulations and the effectiveness of our patents
and other measures to protect our intellectual property
rights;
- our business and operations in general, including:
implementation of our restructuring plan announced in December
2017; our ability to attract, hire and retain highly skilled
personnel; our ability to develop and commercialize additional
pharmaceutical products; compliance with anti-corruption, sanctions
and trade control laws; manufacturing or quality control problems;
interruptions in our supply chain including due to potential
effects of the COVID-19 outbreak on our operations in geographic
locations impacted by the outbreak and on the business operations
of our customers and suppliers; disruptions of information
technology systems; breaches of our data security; variations in
intellectual property laws; challenges associated with conducting
business globally, including adverse effects of political or
economic instability, major hostilities or terrorism; 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; our prospects and
opportunities for growth if we sell assets and potential
difficulties related to the operation of our new global enterprise
resource planning (ERP) system;
- compliance, regulatory and litigation matters, including:
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications in the U.S. and our
ability to reach a final resolution of the remaining opioid-related
litigation; costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; governmental investigations
into S&M practices; potential liability for patent
infringement; product liability claims; increased government
scrutiny of our patent settlement agreements; failure to comply
with complex Medicare and Medicaid reporting and payment
obligations; and environmental risks;
and other factors discussed in our Annual Report on Form 10-K
for the year ended December 31, 2019, 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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IR United States Kevin C. Mannix (215)
591-8912
Ran Meir 972 (3) 926-7516
PR United States Israel Doris Li
973-295-7563
Yonatan Beker 972 (54) 888 5898
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