16 presentations will examine safety and
efficacy of AJOVY and AUSTEDO
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced new data for
two of the company’s neurology portfolio treatments, AJOVY®
(fremanezumab-vfrm) injection and AUSTEDO® (deutetrabenazine)
tablets. These data will be presented at the American Academy of
Neurology (AAN) Annual Meeting on April 2-7, 2022 in person and
virtually on April 24-26, 2022.
“Our commitment to improving the lives of patients suffering
from migraine and movement disorders is paramount, which is why we
are proud to add to the growing body of evidence supporting the
safety and efficacy of AJOVY and AUSTEDO across different patient
populations and subgroups, in addition to findings on
migraine-related healthcare resource utilization costs,” said
Denisa Hurtukova, MD, VP, Head of North America Medical Affairs.
“We look forward to gathering in person at AAN and continuing to
share results from our robust data sets to add to clinicians'
understanding of these treatments.”
At this year’s AAN, Teva will highlight safety and efficacy of
AJOVY data across populations from different regions and
ethnicities, as well as differing disease severity and risk
factors. AJOVY data presented at the meeting spans 11 abstracts,
including a 6-month safety and efficacy pooled analysis from the
Phase 3 FOCUS and HALO studies, and an analysis on efficacy and
disability outcomes in patients treated with AJOVY with prior
onabotulinumtoxinA treatment failure. Real-world data will be
presented regarding reductions in acute medication use for migraine
patients initiating AJOVY, as well as a study evaluating healthcare
resource use of patients initiating AJOVY.
Teva will also highlight long-term post hoc analyses in patients
with tardive dyskinesia (TD) treated with AUSTEDO from the 3-year
open label RIM-TD study, examining safety and efficacy outcomes by
underlying comorbid psychiatric illness or mood disorder,
dopamine-receptor antagonist (DRA) use and dose patterns by TD
severity. Additional abstracts include a survey of patients and
caregivers in the U.S. examining the burden of TD on patients’
physical, psychological and social well-being, as well as a
sentiment analysis of unstructured electronic medical records (EMR)
data of patients with Huntington’s disease (HD) or TD.
This year’s annual AAN meeting is being offered both fully in
person and virtually. Data presentations can be accessed by
registering for the meeting.
The full set of data sponsored by Teva includes:
AJOVY:
De novo:
- Six-Month Safety and Efficacy of Fremanezumab in Migraine:
Pooled Analysis from the Phase 3 FOCUS and HALO Studies
(S31.007)
- Efficacy and Disability Outcomes of Fremanezumab in Patients
With Prior OnabotulinumtoxinA Treatment Failure: Pooled Results of
3 Randomized, Double-Blind, Placebo-Controlled Phase 3 Studies
(P3.004)
- Reductions in Acute Medication Use for Patients with Migraine
Initiating Fremanezumab: Results of a Long-Term US Claims Database
Analysis (P16.005)
- Reductions in Migraine-Related Health Care Resource Utilization
and Costs for Patients Initiating Fremanezumab: Results of a
Long-Term US Claims Database Analysis (P12.002)
- Direct Health Care Costs of Patients Suffering With Migraine in
Southern Israel: a Retrospective Database Analysis (P17.006)
Encore:
- Timing and Location of Injection-Site Adverse Events With
Fremanezumab in Patients with Migraine: A Pooled Analysis of Phase
3 Studies (P16.003)
- Changes in Heart Rate and Blood Pressure in Participants
Treated With Fremanezumab for Migraine: A Pooled Analysis of Phase
3 Studies (P3.003)
- Migraine Epidemiology in Southern Israel: A Retrospective
Database Study (P17.004)
- Prescription Opioids in Patients With Migraine in Southern
Israel: a Retrospective Database Analysis (P17.001)
- Fremanezumab for Preventive Treatment in Migraine: The FINESSE
Study (P16.001)
- Safety and Efficacy of Fremanezumab in Different Racial and
Ethnic Subgroups of Patients With Migraine: A Pooled Analysis of
Phase 3 Studies (P1.004)
AUSTEDO:
De novo:
- Sentiment Analysis of Unstructured Electronic Medical Record
Data of Patients Treated With Vesicular Monoamine Transporter 2
Inhibitors in Huntington’s Disease and Tardive Dyskinesia
(P3.006)
Encore:
- Dose Patterns for Long-Term Deutetrabenazine Treatment in
Patients With Tardive Dyskinesia by Baseline Abnormal Involuntary
Movement Scale Item 8 Score (P9.001)
- Effects of Long-Term Deutetrabenazine Treatment in Patients
With Tardive Dyskinesia and Underlying Psychiatric or Mood
Disorders (P9.002)
- Long-Term Efficacy and Safety of Deutetrabenazine in Patients
With Tardive Dyskinesia by Concomitant Dopamine-Receptor Antagonist
Use (P6.001)
- Impact of Tardive Dyskinesia on Physical, Psychological, and
Social Aspects of Patient Lives: A Survey of Patients and
Caregivers in the United States (P6.005)
About AJOVY (fremanezumanb-vfrm) Injection
AJOVY is available as a 225 mg/1.5 mL single dose injection in a
prefilled syringe or autoinjector with two dosing options – 225 mg
administered monthly 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. AJOVY is now approved
in 45 countries worldwide.
Indications and Usage
AJOVY is a calcitonin gene-related peptide antagonist indicated
for the preventive treatment of migraine in adults.
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) 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. TD is a
movement disorder that 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. Safety and effectiveness in pediatric patients have
not been established.
Indications and Usage
AUSTEDO (deutetrabenazine) tablets is 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 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,
biosimilar 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, 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
commercialize AJOVY and AUSTEDO; our ability to successfully
compete in the marketplace, including 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; our business and operations in general,
including uncertainty regarding the COVID-19 pandemic and the
governmental and societal responses thereto, 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, 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;
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, 2021,
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220401005104/en/
IR Contacts United States Ran Meir +1-267-638-8167
Israel Yael Ashman 972 (3) 914-8262
PR Contacts United States Doris Li (973) 265-3752
Yonatan Beker (973) 917-0851
Teva Pharmaceutical Indu... (NYSE:TEVA)
過去 株価チャート
から 6 2024 まで 7 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
過去 株価チャート
から 7 2023 まで 7 2024