Teva’s AJOVY® Receives EU Approval Offering Patients the First & Only Anti-CGRP Treatment with Both Quarterly & Monthly Do...
01 Avril 2019 - 2:08PM
Business Wire
- In clinical trials, many patients on
AJOVY experienced significant reductions of at least 50% in the
number of monthly migraine days with reduction observed as early as
week one1,2
- Migraine is the most prevalent
neurological disorder affecting more than 50 million people in
Europe and 1 billion worldwide3,4
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that the European Commission (EC) has granted the
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. AJOVY is
a humanized monoclonal antibody (mAb) that binds to the calcitonin
gene-related peptide (CGRP) ligand and blocks its binding to the
receptor. AJOVY is the first and only anti-CGRP drug approved in
the European Union (EU) and the United States (US) that is designed
for the prevention of migraine that offers both quarterly and
monthly dosing options for the phrophylatic treatment of
migraine.
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AJOVY capshot (Graphic: Business
Wire)
Elena Ruiz de la Torre, Executive Director, European Migraine
& Headache Alliance (EMHA) said: “Migraine is not just a
headache, it is an unpredictable neurological disease which can
frequently go undiagnosed and undertreated. After decades of
migraine patients feeling left behind, we are delighted to see the
progression of preventive treatments which offer patients new hope
in managing their condition. The availability of a new treatment,
which is specifically designed for the prevention of migraine, is
another positive step forward for the migraine community and we
welcome the fact that Europe’s more than 50 million patients will
now have greater choice over their treatment options and more days
uninterrupted by migraine."
AJOVY was evaluated in two pivotal Phase III clinical trials
that enrolled patients with disabling migraine and studied
fremanezumab as a prophylactic treatment for 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 fremanezumab
were mostly mild to moderate, short-lasting skin reactions around
the injection area: pain, hardening, redness, itching and rash at
the injection site.
Messoud Ashina, Professor of Neurology in the Faculty of Health
and Medical Sciences, University of Copenhagen, Denmark, stated:
“Migraine is a debilitating neurological disease which can have a
substantial impact on quality of life. The disease is most common
between the ages of 25 and 55 meaning that it strikes during the
most productive years, disrupting patients’ personal and
professional lives. The approval of fremanezumab in the EU will
provide European physicians with an important new treatment option
offering patients greater flexibility through monthly and quarterly
dosing options and, most importantly, a significant reduction in
the number of migraine days.”
Richard Daniell, Executive Vice President, European Commercial
at Teva said: “Migraine can have a significant impact on the
day-to-day life of patients with some experiencing 15 headache days
per month. It is our hope that AJOVY® will provide patients and
European healthcare professionals with a preventive treatment which
offers patients more migraine free days as well as greater
flexibility in managing this unpredictable disease. The approval of
fremanezumab is also an important step in our focus on
biopharmaceuticals, the next generation of innovative medicines,
coupled with our ongoing commitment to developing treatments for
disorders of the central nervous system (CNS).”
The EC decision is applicable to all 28 EU member states plus
Iceland, Norway and Liechtenstein after transposition into legally
binding acts in these countries. AJOVY received U.S. FDA approval
for the preventive treatment of migraine in adults on 14 September
2018. Additional regulatory filings are underway with other health
authorities worldwide.
About AJOVY®
AJOVY (fremanezumab) is indicated for the prophylaxis of
migraine in adults who have at least four migraine days per month.
AJOVY is available as a 225 mg/1.5mL single dose injection in a
prefilled syringe with two dosing options – 225 mg monthly
administered as one subcutaneous injection, or 675 mg every three
months (quarterly), administered as three subcutaneous injections.
AJOVY can be administered in by a healthcare professional or at
home by a patient or caregiver if instructed by a healthcare
professional in subcutaneous self-injection technique.
About Teva
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 43,000
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 EU approval of 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 uncertainty of commercial success
of AJOVY;
- our ability to successfully compete in
the marketplace, including: that we are substantially dependent on
our generic products; competition for our specialty products,
especially COPAXONE®, our leading medicine, which faces competition
from existing and potential additional generic versions and
orally-administered alternatives; the uncertainty of commercial
success of AUSTEDO®; competition from companies with greater
resources and capabilities; efforts of pharmaceutical companies to
limit the use of generics, including through legislation and
regulations; consolidation of our customer base and commercial
alliances among our customers; the increase in the number of
competitors targeting generic opportunities and seeking U.S. market
exclusivity for generic versions of significant products; price
erosion relating to our products, both from competing products and
increased regulation; delays in launches of new products and our
ability to achieve expected results from investments in our product
pipeline; our ability to take advantage of high-value
opportunities; the difficulty and expense of obtaining licenses to
proprietary technologies; 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: failure to effectively execute our restructuring plan
announced in December 2017; uncertainties related to, and failure
to achieve, the potential benefits and success of our new senior
management team and organizational structure; harm to our pipeline
of future products due to the ongoing review of our R&D
programs; our ability to develop and commercialize additional
pharmaceutical products; potential additional adverse consequences
following our resolution with the U.S. government of our FCPA
investigation; compliance with sanctions and other trade control
laws; 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 failure to recruit or retain key personnel;
variations in intellectual property laws that may adversely affect
our ability to manufacture our products; challenges associated with
conducting business globally, including adverse effects of
political or economic instability, major hostilities or terrorism;
significant sales to a limited number of customers in our U.S.
market; 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: 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; governmental investigations
into selling and marketing practices; potential liability for
patent infringement; 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;
- 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; 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 our Annual Report on
Form 10-K for the year ended December 31, 2018, including the
sections thereof 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.
1 Dodick DW et al. JAMA 2018; 319(19): 1999–2008
2 Silberstein SD et al. N Engl J Med 2017; 377(22):
2113–2122
3 Headache. EAN. Available at:
https://www.ean.org/index.php?id=2796 Accessed: 22 February
2019
4 Migraine Research Foundation, Migraine Facts. Available at:
http://migraineresearchfoundation.org/about-migraine/migraine-facts/
Accessed: 22 February 2019
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IR ContactsUnited StatesKevin C. Mannix(215)
591-8912
IsraelRan Meir972 (3) 926-7516
PR ContactsEuropeFiona Cohen+31 620082545
United StatesDoris Saltkill+1 (913) 777-3343
IsraelYonatan Beker972 (54) 888 5898
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