- Pooled analysis of fremanezumab Phase 3 studies indicates a
positive cardiovascular safety profile in adult patients
- Further data on injection-related adverse events provides
fresh guidance for healthcare professionals in optimal selection of
injection sites
A new analysis presented by Teva Pharmaceutical Industries Ltd.
(NYSE and TASE: TEVA) on AJOVY® (fremanezumab) injection for the
preventive treatment of migraine, indicates to the European
neurology community that the medicine has a positive safety profile
in relation to risk of cardiovascular events.
The data, drawn from an analysis of three published Phase 3
studies of fremanezumab and presented at the 7th Congress of the
European Academy of Neurology (EAN), showed minimal changes in the
heart rate and blood pressure of those patients studied over a 12
week period. 1
“As a CGRP inhibitor, fremanezumab has been shown to provide
protection against migraine in suitable patients, and we remain
focused on continued assessment of the safety profile of this
therapy, particularly in relation to heart-related issues as it is
believed CGRP itself acts as a ‘safeguard’ during cardiovascular
ischemia and other events,” said Dr Joshua M. Cohen, Senior
Director and Global Therapeutic Area Lead, Migraine and Headache,
Teva.
“These new data offer the neurology prescribing community added
confidence and further reassurance that any CV risks associated
with fremanezumab use are minimal, particularly in relation to
concerning issues such as hypertension.”
The data were arrived at following a pooled analysis of the HALO
episodic migraine [EM], HALO chronic migraine [CM], and FOCUS Phase
3 clinical trials, which were designed to assess (fremanezumab) in
the preventive treatment of migraine in adults. They are the first
data to suggest that changes in heart rate and blood pressure
remain unaffected by the action of any calcitonin gene-related
peptide (CGRP) inhibitor when used at its recommended dose.
Fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa),
selectively targets the CGRP ligand.1 Potential effects of CGRP
inhibition are important for patients as this peptide has been
described to have a cardioprotective role, particularly during
ischemic events, and migraine patients are well known to carry a
potentially higher risk of stroke and myocardial infarction.2
Across the phase 3 studies, 1,897 patients received fremanezumab
(quarterly, n=943; monthly, n=954) and 945 received placebo. At the
end of 12 weeks of double-blind treatment, mean increases from
baseline in heart rate (measured in beats per minute) were minimal,
as were decreases in systolic (SBP) and diastolic (DBP) blood
pressure (measured in mmHg) for the population studies. None of
these changes were deemed clinically significant.1
“EAN is among the premier annual meetings for professionals
invested in the ongoing improvement of clinical practice in
neurology,” said Dr Cohen.
“Teva is excited to continue its close working partnership with
the Academy and is grateful to have this important platform to
deliver fresh insights on the cardiovascular profile of
fremanezumab and give neurologists more evidence and confidence in
its use as an important migraine therapy.”
Additional data presented confirms most adverse events occur
within the first month of treatment and are more common in the limb
than abdominal region
Further data taken from the pooled analysis of HALO EM, HALO CM,
and FOCUS may improve the guidance prescribers can give to patients
around managing potential issues at injection sites.
Injection site adverse events were shown to be most common in
the first month following the start of treatment, and when taken
quarterly or monthly, were seen to be more common in a limb rather
than the abdomen.
“Most injectable therapies carry a risk of adverse events at the
injection site, and our data are providing some useful guidance
that could indicate abdominal injections may be a preferable choice
for patients, where fewer events were detected as opposed to
injection via a limb. This may feel like a relatively small
consideration in the grander scheme of assessing overall efficacy
and safety, but it is an important consideration for individuals
who have been prescribed the medicine,” said Dr Cohen.
This pooled analysis included 2,842 patients. In the quarterly
fremanezumab (n=943), monthly fremanezumab (n=954), and placebo
(n=945) groups, respectively, injection-site AEs were reported for
37%, 37%, and 31% of patients, most commonly pain (22%, 20%, and
20%), induration (15%, 18%, and 13%), and erythema (16%, 15%, and
12%). These AEs were most common within the 1 month of initiating
study treatment. With quarterly fremanezumab, monthly fremanezumab
and placebo, injection-site AEs were more common in the limb than
in the abdomen.3
Accessing EAN 2021 Presentations
The ePresentations shared by Teva at EAN 2021 can be accessed by
healthcare professionals via the EAN conference website, and
available on-demand for EAN members.
Additional resources on migraine, including articles,
publication summaries, podcasts and webinars can be accessed at
Neurologybytes. Neurologybytes is a platform published by Teva to
support neurologists in accessing timely, bite-sized content on the
latest research developments and clinical care perspectives in the
world of migraine and multiple sclerosis (MS).
Information for Europe about AJOVY® from the European Medicines
Agency (EMA) can be found here.
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.
Important factors that could cause or contribute to such
differences include risks relating to:
- 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, 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.
References
- Naegel S. EAN 2021 Pooled HALO-FOCUS HR, SBP, DBP. TGT-70183
EAN21 Pooled HALO-FOCUS HR, SBP, DBP.doc; 1/12/2021.
- Rubio-Beltrán E, van den Brink AM. Understanding CGRP and
Cardiovascular Risk. Handb Exp Pharmacol. 2019;255:131-140. doi:
10.1007/164_2019_204. PMID: 30879200.
- Jurgens T. EAN 2021 Pooled HALO CM, HALO EM, FOCUS
injection-site AEs. TGT-70182 EAN 2021 Pooled HALO-FOCUS
injection-site AEs.doc; 1/12/2021
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version on businesswire.com: https://www.businesswire.com/news/home/20210621005180/en/
PR Contacts Fiona Cohen, Teva Europe
Fiona.Cohen@TevaEU.com +31 6 20 08 25 45
Con Franklin, Ketchum con.franklin@ketchum.com +44 (0) 7974 434
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