Late-breaking abstract highlights a network
meta-analysis on monthly migraine day reductions with AJOVY,
Nurtec® ODT (Rimegepant) and Atogepant in the preventive treatment
of episodic migraine
Showcasing Teva’s Commitment to Helping
Patients Have More Migraine-Free Days, 18 Abstracts will be
presented, Including One Late-Breaker, on AJOVY®
(fremanezumab-vfrm) Injection at the International Headache Society
and European Headache Federation Joint Congress 2021
Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today
announced that 17 presentations, including one late-breaker,
examining post hoc, real-world and survey data for AJOVY
(fremanezumab-vfrm) injection will be presented at the
International Headache Society and European Headache Federation
Joint Congress, taking place virtually on Sept. 8-12, 2021.
“Migraine affects over a billion people worldwide1, and its
impact is felt by patients, caregivers, and society as a whole all
around the world. We continue to advance the clinical understanding
of how AJOVY can help more people have more days free from
migraine,” said Matthias Mueller, MD MSc, VP Global Medical Affairs
- Global Therapeutic Areas and Scientific Communications at Teva.
“The data to be presented at the joint congress bring us one step
closer to understanding how AJOVY might extend the time between
migraine attacks to help lessen the impact of migraine
worldwide.”
Late-breaking data being presented include a fixed-effect
Bayesian network meta-analysis (NMA) assessing relative efficacy
for monthly and quarterly AJOVY, daily and twice daily Atogepant
and every other day Rimegepant for the preventive treatment of
episodic migraine (EM).
Additional data being presented include Phase 3 post hoc
analyses assessing:
- Headache-free days (HFD) and migraine-free days (MFD) gained in
patients using fremanezumab from a one-year extension study of the
HALO long-term study (LTS).
- The maximum number of consecutive MFD for patients treated with
fremanezumab after inadequate response to 2-4 prior migraine
preventive medication classes in the FOCUS trial.
- The shift in migraine frequency category for participants
treated with fremanezumab from a pooled analysis of three Phase 3,
double-blind, placebo-controlled trials: HALO CM, HALO EM and
FOCUS.
Teva will host an online symposium, “The Spectrum of CGRP
Monoclonal Antibodies: Bringing the science to clinical practice,”
on Thursday, September 9 from 17:45-19:15 CEST, after which will be
available for on-demand viewing. The symposium will be led by
Simona Sacco, Professor of Neurology, University of L'Aquila,
Italy, and feature perspectives from Professor Zaza Katsarava, Dr.
Deb Friedman and Dr. Larry Charleston, IV on topics including the
right patients and timing for treatment with CGRP mAbs, effective
migraine prevention beyond headache, and real-world study efficacy,
with a focus on complementing clinical trials and validating use in
clinical practice.
Teva will also host a Meet the Expert Live session on September
10 from 17:30-18:00 CEST, after which will be available for
on-demand viewing, that will discuss the current state of
healthcare disparities in headache medicine both in practice and in
research. The focus will include diversity, equity and inclusion
disparities across diverse populations, as well as a discussion on
potential solutions leading to optimal outcomes. “Migraine does not
discriminate, and we’ll discuss disparities in headache medicine
across diverse populations during our Meet the Expert session.
Every patient should have an opportunity to experience fewer days
with migraine and headache, and addressing disparities in migraine
management is a core value of our work at Teva,” said Matthias
Mueller, MD MSc, VP Global Medical Affairs - Global Therapeutic
Areas and Scientific Communications at Teva.
This year’s joint IHC/EHF meeting is fully virtual. Data
presentations can be accessed by registering for the meeting.
The full set of Teva-sponsored AJOVY data to be presented
includes:
De novo
- Network Meta-analysis on Monthly Migraine Day Reductions With
Fremanezumab, Rimegepant, and Atogepant in the Prevention of
Episodic Migraine
- Time Gained With Long-term Fremanezumab Treatment in Patients
With Chronic and Episodic Migraine
- Pooled analysis of the timing and location of injection-site
adverse events with fremanezumab in patients with migraine
- Changes in the Number of Non-headache Days and Functioning on
Those Days With Fremanezumab Treatment in Patients With Migraine: A
Pooled Analysis
- Efficacy of Fremanezumab in Migraine Patients With Pain or
Psychiatric Comorbidities and Documented Inadequate Response to 2-4
Prior Migraine Preventive Medication Classes
- Responder Rates for Reductions in Nausea or Vomiting and
Photophobia and Phonophobia in Patients Treated With Fremanezumab
in the HALO CM, HALO EM, HALO LTS, and FOCUS Studies
- Long-term Tolerability and Improvements in Disability and
Quality of Life With Fremanezumab in Patients With Chronic or
Episodic Migraine and Documented Inadequate Response to 2-4 Prior
Classes of Migraine Preventive Medications
- Reductions in Migraine Frequency With Fremanezumab Treatment in
Individuals With Chronic and Episodic Migraine
- Long-term Fremanezumab Treatment Over 6 to 12 Months Shows No
Effect on Blood Pressure in Migraine Patients
- Consecutive Migraine-free Days With Fremanezumab Treatment:
Results of the Double-blind, Placebo-controlled FOCUS Study
- Long-term Efficacy of Fremanezumab in Patients With Chronic or
Episodic Migraine and Documented Prior Inadequate Response to 2-4
Classes of Migraine Preventive Medications
- FINESSE: Fremanezumab for Preventive Treatment in Migraine
Encore
- Migraine Burden and Impact: Survey Results From 6 Countries in
South America, Asia, and Australia
- Impact of Fremanezumab Treatment on Clinical Outcomes Among
Migraine Patients With Comorbid Depression, Anxiety or Hypertension
in a Real-World Setting
- Pooled Analysis of the Effectiveness of Fremanezumab in
Patients With Lower- and Higher-frequency Chronic Migraine
- Pooled Analysis of the Efficacy of Fremanezumab in Persons With
Moderate- and Higher-frequency Episodic Migraine
- Patient Perception of Migraine Impact and Burden: Survey
Results From 10 European Countries
- Primary Headache Disorders and Acute Medications Associated
With Medication Overuse Headache: Analysis of US Claims Data
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.
References
1Migraine Facts. Migraine Research Foundation. Accessed June
2021.
https://migraineresearchfoundation.org/about-migraine/migraine-facts/
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