Extension analyses observed patients taking
AJOVY experienced a reduction in migraine and headache days and
evaluated disability and health-related quality of life
Online symposium to highlight healthcare and
neurology disparities as a major public health issue and discuss
the state of diversity in migraine clinical studies, barriers to
recruitment, and the need for more inclusive and diverse
studies
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today
announced that 8 presentations examining Phase 2b/3 data, pooled
analyses and open-label extension (OLE) study data for AJOVY
(fremanezumab-vfrm) injection will be presented at the 25th World
Congress of Neurology (WCN), taking place virtually on Oct. 3-7,
2021.
“The data being presented at this year's WCN meeting aid in
expanding our knowledge of migraine so we can continue to better
understand this treatment option,” said Matthias Mueller, MD MSc,
VP Global Medical Affairs at Teva.
Featured data include pooled analyses of different trials
examining outcomes related to efficacy and safety, quality of life
and disability in patients with different migraine frequency,
patients who have inadequate response to previous preventive
treatments, patients within different ethnic subgroups and patients
with medication overuse headache.
Addressing healthcare disparities within migraine treatment is a
key area of focus. A recent review of literature published in
Neurology shows how disparities in race, ethnicity, socioeconomic
status, geography, and other factors contribute to the inequitable
treatment of those diagnosed with headache disorders.1
Teva will host an online symposium, “Envisioning a More
Inclusive, Diverse and Equitable Global Migraine Landscape: Are We
Making Progress?” on Oct. 3, from 14:00 – 15:30 CEST. The symposium
will be led by Cristina Tassorelli (Chair), with Larry Charleston,
Cynthia Armand, Bronwyn Jenkins and Gisela Terwindt, discussing
disparities in healthcare and neurology, underrepresentation in
neurology and migraine clinical trials, and data on the efficacy
and safety of anti-CGRP mAbs in patients with different demographic
and non demographic characteristics. This session will also be
available for on-demand viewing following the live session.
The symposium is designed to address the following
objectives:
- Build awareness of healthcare disparities as a major public
health issue by highlighting social determinants of health and
defining concepts and terms relevant to understanding health
disparities and diversity
- Critique the state of diversity in migraine clinical studies,
review barriers to recruitment, and discuss the need for more
inclusive and diverse studies
- Examine inclusivity of anti-CGRP mAb clinical studies
specifically, and review latest data from diverse sub-populations,
e.g. different ethnicities, migraine characteristics and
comorbidities
“To help ensure migraine patients are receiving the care they
need, it's important to understand all factors that contribute to a
person’s health and disease state. Both demographic and non
demographic factors are important to consider when treating our
patients. We are excited to lead this conversation to help build
awareness around health disparities to ensure more equity in
neurology treatment,” said Matthias Mueller, MD MSc, VP Global
Medical Affairs at Teva.
The full set of abstracts approved by the congress scientific
committee and sponsored by Teva include:
De novo
- “Fremanezumab Improves Quality of Life in Patients With Higher-
and Lower-Frequency Chronic Migraine”
- “Fremanezumab Improves Quality of Life in Patients With High-
and Moderate-Frequency Episodic Migraine”
- “Efficacy and Improvements in Disability and Quality-of-Life
With Fremanezumab Over 6 Months in Migraine Patients With
Inadequate Response by Multiple Prior Preventive Treatment
Classes”
- “Reversion From Medication Overuse With Fremanezumab Treatment
in Patients With Inadequate Response to Multiple Migraine
Preventive Medication Classes”
- “Progressive Improvements in Efficacy and Disability With
Fremanezumab in Patients With Medication Overuse And Inadequate
Response to Multiple Migraine Preventive Medication Classes”
- “Efficacy Of Fremanezumab in Patients With Chronic and Episodic
Migraine Stratified by Migraine Frequency”
- “Efficacy And Tolerability of Fremanezumab for Migraine
Preventive Treatment in Korean Patients With Chronic or Episodic
Migraine”
- “Pooled Analysis of Safety and Efficacy of Fremanezumab in
Different Racial and Ethnic Subgroups of Patients With
Migraine”
Information for Europe about AJOVY▼ can be found
here.
▼Adverse events should be reported. 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. Reporting forms
and information can be found at https://www.hpra.ie. Adverse events
should also be reported to Teva – please refer to local
numbers.
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. 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.
Please click here for full U.S. Prescribing Information for
AJOVY (fremanezumab-vfrm) injection.
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, 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 commercial success of
AJOVY; 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 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, 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, 2020,
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 Kiarashi J, VanderPluym J, Szperka CL, et al. Factors
associated with, and mitigation strategies for, healthcare
disparities faced by patients with headache disorders. Neurology.
Published online June 9, 2021.
doi:10.1212/WNL.0000000000012261.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210930005042/en/
IR Contacts
United States Kevin C. Mannix (215) 591-8912
Israel Yael Ashman 972 (3) 914-8262
PR Contacts
United States Doris Li (973) 265-3752
United States Yonatan Beker (973) 917-0851
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Apr 2023 to Apr 2024