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If Approved, AJOVY will be the First and Only Anti-CGRP Treatment
with Quarterly and Monthly Dosing Options in the European Union
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that the Committee for Medicinal Products for Human Use (CHMP)
of the European Medicines Agency (EMA) has recommended granting a
marketing authorization for AJOVY® (fremanezumab) 225 mg
solution for injection in pre-filled syringe for the prophylaxis of
migraine in adults who have at least four migraine days per month. If
approved by the European Commission (EC), AJOVY, a humanized monoclonal
antibody that binds to the calcitonin gene-related peptide (CGRP) ligand
and blocks its binding to the receptor, will be the first and only
anti-CGRP treatment in the European Union (EU) with both quarterly and
monthly dosing options.
Migraine is a disabling neurological disease often accompanied by
nausea, vomiting, photophobia, phonophobia and changes in vision.1
Globally, there are approximately one billion people affected by migraine2,
with more than 50 million people suffering from the disease across
Europe.3 It is estimated that the total annual cost of
migraine in Europe is €111 billion.4
“We are very pleased to report a positive opinion by the CHMP,” said
Richard Daniell, Executive Vice President, European Commercial at Teva.
“This is another important milestone for us and the migraine community
as a whole. We hope to expand the availability of AJOVY to the EU so
that eligible patients can potentially benefit from the flexibility
AJOVY offers through quarterly and monthly dosing options.”
The positive CHMP opinion is based on the review of a Marketing
Authorization Application (MAA) that included efficacy and safety data
from the HALO clinical development program. The program evaluated
fremanezumab in two pivotal Phase III clinical trials that enrolled
patients with disabling migraine and studied fremanezumab as a
prophylaxis of migraine in adults. In these trials, patients treated
with fremanezumab had a significantly greater reduction in migraine days
compared to placebo. Adverse drug reactions (ADRs) observed with AJOVYwere mostly mild to moderate, short-lasting skin reactions around
the injection area: pain, hardening, redness, itching and rash at the
“Migraine is the most prevalent disabling neurological disease in
Europe,” said Professor Peter J. Goadsby, MD, PhD, Professor of
Neurology at King's College, London. “It is the second most common cause
of years lost to disability in the world, interrupting patients during
their most active and productive years. Migraine disrupts their work and
family lives at a time when others rely on them the most. Many patients
have to live in fear of their next attack; the most disabled have
chronic migraine, experiencing 15 or more days of illness per month.
Fremanezumab is an anti-CGRP monoclonal antibody (mAb) specifically
developed for migraine, and if approved for use in the EU, it will offer
an additional treatment option for patients and more flexibility in
managing their condition.”
The positive CHMP opinion is a formal recommendation to grant the
marketing authorization for AJOVY in the EU. The recommendation will now
be reviewed by the EC, which has authority to approve medicines for use
in the 28 countries of the EU. A final decision is expected in the first
half of 2019.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global
leader in generic medicines, with innovative treatments in select areas,
including CNS, pain and respiratory. We deliver high-quality generic
products and medicines in nearly every therapeutic area to address unmet
patient needs. We have an established presence in generics, specialty,
OTC and API, building on more than a century-old legacy, with a fully
integrated R&D function, strong operational base and global
infrastructure and scale. We strive to act in a socially and
environmentally responsible way. Headquartered in Israel, with
production and research facilities around the globe, we employ 45,000
professionals, committed to improving the lives of millions of patients.
Learn more at www.tevapharm.com.
Teva 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 Fremanezumab (commercialized in the United States as 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:
and other factors discussed in our Annual Report on Form 10-K for the
year ended December 31, 2017, including in the section captioned “Risk
Factors,” and in our other filings with the U.S. Securities and Exchange
Commission, which are available at
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
1 IHS classification – Migraine classification criteria.
2 Migraine Facts, Migraine Research Foundation. Available at https://migraineresearchfoundation.org/about-migraine/migraine-facts/.
Accessed January 2019.
3 Headache. EAN. Available at: https://www.ean.org/index.php?id=2796.
Accessed January 2019.
4 Linde M1 Gustavsson A, Stovner LJ et al. 2011. The cost of
headache disorders in Europe: the Eurolight project. [Online] Available
Accessed January 2019.
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Kevin C. Mannix(215) 591-8912Ran Meir972
(3) 926-7516PR ContactsUnited StatesDoris
Saltkill(913) 777-3343IsraelYonatan Beker972
(54) 888 5898
Source: Teva Pharmaceutical Industries Ltd.