European Medicines Agency (EMA) Accepts Fremanezumab Marketing Authorization Application
February 02 2018 - 7:00AM
Business Wire
Teva seeking EU regulatory approval for
anti-CGRP therapy for the prevention of migraine
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced that the European Medicines Agency (EMA) has
accepted the Marketing Authorization Application (MAA) for
fremanezumab, an anti-calcitonin gene-related peptide (CGRP)
antibody for the prevention of episodic and chronic migraine in
adults. Fremanezumab is a quarterly or monthly injection that may
be administered by a healthcare professional, or self-administered
by the patient.
“The successful filing of the MAA for fremanezumab with the EMA
builds on the momentum of the global fremanezumab program,
following acceptance of the Biologics License Application with the
U.S. Food and Drug Administration,” said Ernesto Aycardi, MD, Vice
President Head of Clinical Trial Execution, Data Sciences and
Biometrics & Clinical Pharmacology at Teva. “With limited
availability of preventive therapy options that target the
underlying biological mechanisms of migraine, the MAA acceptance
represents a major step toward advancing the treatment paradigm for
the migraine community. These two significant regulatory milestones
in the migraine indication, combined with our clinical development
programs for fremanezumab in cluster headache and post-traumatic
headache, highlight Teva’s commitment to patients worldwide with
these debilitating conditions.”
The MAA includes data from the HALO clinical trial program,
which enrolled more than 2,000 patients with episodic migraine (EM)
and chronic migraine (CM), evaluating both quarterly and monthly
dosing regimens, in which fremanezumab achieved statistically
significant results across all trial endpoints. The most common
adverse events reported in clinical trials include injection site
pain, induration, and erythema.
About the HALO Clinical Research Program
The Phase III HALO EM and CM studies were 16-week, multicenter,
randomized, double-blind, placebo-controlled, parallel-group
studies to compare the safety, tolerability, and efficacy of four
dose regimens of subcutaneous fremanezumab compared to placebo in
adults with episodic and chronic migraine. The studies consisted of
a screening visit, a 28-day run-in period, and a 12-week (84-day)
treatment period, including a final evaluation at week 12
(end-of-treatment [EOT] visit, four weeks [28 days] after the final
dose of study drug).
- In the EM study, 875 patients were
enrolled (294, 291, and 290 patients in the placebo, quarterly, and
monthly dose groups, respectively). Patients were randomized in a
1:1:1 ratio to receive subcutaneous injections of fremanezumab at
225 mg for three months (monthly dose regimen), fremanezumab at 675
mg at initiation followed by placebo for two months (quarterly dose
regimen), or three monthly doses of matching placebo. The primary
efficacy endpoint of the EM study was the mean change from baseline
(28-day run-in period) in the monthly average number of migraine
days during the 12-week period after the first dose of
fremanezumab.
- In the CM study, 1,130 patients were
randomized (around 376 patients per treatment group). Patients were
randomized in a 1:1:1 ratio to receive subcutaneous injections of
fremanezumab at 675 mg at initiation followed by monthly 225 mg for
two months (monthly dose regimen), fremanezumab at 675 mg at
initiation followed by placebo for two months (quarterly dose
regimen), or three monthly doses of matching placebo. The primary
efficacy endpoint of the CM study was the mean change from baseline
(28-day run-in period) in the monthly average number of headache
days of at least moderate severity during the 12-week period after
the first dose of fremanezumab.
About Fremanezumab
Fremanezumab is a fully-humanized monoclonal antibody targeting
the CGRP ligand, a well-validated target in migraine. With limited
availability of preventive treatment options, fremanezumab
represents a potential new option to address a significant unmet
medical need.
Fremanezumab is also being investigated for the prevention of
chronic and episodic cluster headache as part of the Phase III
ENFORCE clinical research program, which has been granted fast
track designation by the FDA. Trial participant recruitment is now
underway and the studies are expected to conclude in early 2019.
Fast track designation is intended to facilitate development and
expedite review of drugs to treat serious or life-threatening
conditions. Additionally, Teva has also recently initiated a
fremanezumab Phase II clinical program for the treatment of
post-traumatic headache disorder.
About Migraine
Migraine is an unpredictable neurological disease with symptoms
such as severe head pain and physical impairment that can impact
quality of life and productivity. There are two clinical
manifestations of migraine – chronic, where patients suffer 15 or
more headache days per month, and episodic, where patients have 14
or less headache days per month. Worldwide, approximately 90% of
people diagnosed with migraine have episodic migraine and 10% have
chronic migraine.
With more than 1 billion people affected worldwide, migraine is
the third most prevalent illness in the world and the 6th most
disabling illness in the world. In the U.S., EU5 and Japan, nearly
75 million people suffer from episodic and chronic migraine. In the
EU5, more than 15 million people suffer from episodic and chronic
migraine. According to the most recent Cost of Brain Disorders in
Europe paper, migraine costs the economy €18 billion annually in
reduced productivity and work days lost. Of the approximately 40%
of patients suffering from migraine for whom prevention is
appropriate, only 13% are currently receiving therapy. There
remains a significant medical need for treatments designed
specifically to prevent migraine.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by approximately 200
million patients in over 60 markets every day. Headquartered in
Israel, Teva is the world’s largest generic medicines producer,
leveraging its portfolio of more than 1,800 molecules to produce a
wide range of generic products in nearly every therapeutic area. In
specialty medicines, Teva has the world-leading innovative
treatment for multiple sclerosis as well as late-stage development
programs for other disorders of the central nervous system,
including movement disorders, migraine, pain and neurodegenerative
conditions, as well as a broad portfolio of respiratory products.
Teva is leveraging its generics and specialty capabilities in order
to seek new ways of addressing unmet patient needs by combining
drug development with devices, services and technologies. Teva's
net revenues in 2016 were $21.9 billion. For more information,
visit 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 the Fremanezumab Marketing Authorization Application,
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 uncertainty of obtaining regulatory
approvals for Fremanezumab;
- the uncertainty of commercial success
of Fremanezumab;
- our specialty medicines business,
including: competition for our specialty products, especially
Copaxone®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; our ability to achieve expected
results from investments in our product pipeline; competition from
companies with greater resources and capabilities; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our business and operations in general,
including: failure to effectively execute the recently announced
restructuring plan; uncertainties relating to the potential
benefits and success of our new organizational structure and recent
senior management changes; the potential success; our ability to
develop and commercialize additional pharmaceutical products;
manufacturing or quality control problems, which may damage our
reputation for quality production and require costly remediation;
interruptions in our supply chain; disruptions of our or third
party information technology systems or breaches of our data
security; the restructuring of our manufacturing network, including
potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; and variations in
patent laws that may adversely affect our ability to manufacture
our products;
- compliance, regulatory and litigation
matters, including: costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; product liability claims; increased government scrutiny
of our patent settlement agreements; failure to comply with
complex Medicare and Medicaid reporting and payment
obligations; and environmental risks;
- and other factors discussed in our
Annual Report on Form 20-F for the year ended December 31,
2016 (“Annual Report”), including in the section captioned
“Risk Factors,” and in our other filings with the U.S.
Securities and Exchange Commission, which are available at
www.sec.gov and www.tevapharm.com. 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20180202005142/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:Yonatan Beker, 972 (54) 888-5898orUnited
StatesKaelan Hollon, 202-412-7076orMichelle Larkin,
610-786-7335
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