Teva to Present Latest Data on AJOVY® (fremanezumab-vfrm) Injection at the 2021 American Headache Society (AHS) Annual Meeti...
03 June 2021 - 10:00PM
Business Wire
11 presentations examine clinical and
real-world AJOVY data in the reduction of migraine days
Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today
announced that 11 presentations examining clinical and real-world
data for AJOVY® (fremanezumab-vfrm) injection will be presented at
the 2021 American Headache Society (AHS) Annual Meeting, taking
place virtually June 3-6.
“Our goal is to continue supporting the migraine community
through our rigorous and innovative scientific research programs so
we can ultimately uncover the full potential of AJOVY for
patients,” said Denisa Hurtukova, MD, VP, Head of North America
Medical Affairs. “The data being presented at this year’s AHS
meeting underscore the impact AJOVY can have on the healthcare
community as seen in clinical analyses and real-world
experiences.”
Data being presented include results from clinical and
real-world analyses and post-hoc Phase 3 data examining the
long-term response of AJOVY over the course of 15 months, an
analysis of the real-world impact of treatment among patients with
comorbid depression, anxiety or hypertension, as well as a Phase 3b
analysis examining the consistency in migraine days over the course
of a dosing regimen for patients with inadequate responses to 2-4
prior treatments.
This year’s annual AHS 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
- Clinically Meaningful Responses to Fremanezumab Treatment in
Episodic and Chronic Migraine Over Up to 15 Months
- Real-World Impact of AJOVY Use on Clinical Outcomes Among
Migraine Patients With Comorbid Depression, Anxiety or
Hypertension
- No Evidence of Wearing Off Effect for Fremanezumab Treatment in
Chronic and Episodic Migraine Patients With Inadequate Response to
2-4 Prior Classes of Migraine Preventive Medications
- Sustained, Clinically Meaningful Responses to Fremanezumab
Treatment in Migraine Patients With Inadequate Response to 2-4
Prior Classes of Migraine Preventive Medications
- Real-world Reductions in Migraine and Headache Days After
Initiating Fremanezumab for US Patients With Migraine and Prior Use
of Another Monoclonal Antibody Targeting the CGRP Pathway
- Primary Headache Disorders and Acute Medications Associated
With Patients Diagnosed With Medication Overuse Headache: Analysis
of US Claims Data
Encore
- Real-world Data on Reductions in Migraine and Headache Days
With Fremanezumab Treatment for US Patients With Chronic and
Episodic Migraine: Results From a Physician Chart Review Study
- Real-world Data on Quarterly and Monthly Fremanezumab for
Reducing Migraine Days and Headache Days in US Adult Patients With
Migraine: Results From a Physician Chart Review Study
- Real-world Patient Characteristics, Acute Medication Use, and
Treatment Patterns for Patients Initiating Fremanezumab Treatment:
A US Retrospective Claims Analysis
- Real-world Migraine-related Health Care Resource Utilization
and Costs for Patients Initiating Fremanezumab: A US Retrospective
Claims Analysis
- Fremanezumab for Preventive Migraine Treatment in Patients With
Major Depressive Disorder: Protocol for the Randomized,
Placebo-controlled Phase 4 UNITE Study
About AJOVY® (fremanezumab-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
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.
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 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, 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;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; consolidation of our customer base and commercial
alliances among our customers; delays in launches of new generic
products; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; 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, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- 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; effectiveness of our optimization
efforts; our ability to attract, hire and retain highly skilled
personnel; manufacturing or quality control problems; interruptions
in our supply chain; disruptions of information technology systems;
breaches of our data security; variations in intellectual property
laws; challenges associated with conducting business globally,
including political or economic instability, major hostilities or
terrorism; 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; the effects of reforms in
healthcare regulation and reductions in pharmaceutical pricing,
reimbursement and coverage; 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; and our prospects and opportunities for
growth if we sell assets;
- compliance, regulatory and litigation matters, including:
failure to comply with complex legal and regulatory environments;
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications and our ability to
reach a final resolution of the remaining opioid-related
litigation; scrutiny from competition and pricing authorities
around the world, including our ability to successfully defend
against the U.S. Department of Justice criminal charges of Sherman
Act violations; potential liability for patent infringement;
product liability claims; failure to comply with complex Medicare
and Medicaid reporting and payment obligations; compliance with
anti-corruption sanctions and trade control laws; and environmental
risks;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities (including as a result of
potential tax reform in the United States); and the effect on our
overall effective tax rate of the termination or expiration of
governmental programs or tax benefits, or of a change in our
business;
and other factors discussed in this press release and in our
Quarterly Report on Form 10-Q for the first quarter of 2021 and in
our Annual Report on Form 10-K for the year ended December 31,
2020, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210603005194/en/
IR Contacts United States Kevin C. Mannix (215)
591-8912 Yael Ashman 972 (3) 914-8262 PR Contacts United
States Doris Li (973) 265-3752 Israel Yonatan Beker 972
(54) 888 5898
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