Teva Announces U.S. Approval of AJOVYTM (fremanezumab-vfrm) Injection, the First & Only Anti-CGRP Treatment with Both Quarter...
2018年9月15日 - 7:48AM
ビジネスワイヤ(英語)
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that the U.S. Food and Drug Administration (FDA) has
approved AJOVYTM (fremanezumab-vfrm) injection for the preventive
treatment of migraine in adults. AJOVY, a humanized monoclonal
antibody that binds to calcitonin gene-related peptide (CGRP)
ligand and blocks its binding to the receptor, is the first and
only anti-CGRP treatment for the prevention of migraine with
quarterly (675 mg) and monthly (225 mg) dosing options.
“Migraine is a disabling neurological disease that affects more
than 36 million people in the United States,” said Stephen
Silberstein, MD, Director, Jefferson Headache Center at Thomas
Jefferson University Hospital, and lead investigator of the Phase
III clinical trial program for AJOVY. “About 40 percent of people
living with migraine may be appropriate candidates for preventive
treatment, yet the majority of them are untreated. I am pleased to
have another treatment option that may allow my patients to
experience fewer monthly migraine days.”
AJOVY was evaluated in two Phase III, placebo-controlled
clinical trials that enrolled patients with disabling migraine and
was studied as both a stand-alone preventive treatment and in
combination with oral preventive treatments. In these trials,
patients experienced a reduction in monthly migraine days during a
12-week period. The most common adverse reactions (≥5 percent and
greater than placebo) were injection site reactions.
“This is an important day for Teva and complements our
long-standing history of helping patients living with diseases of
the central nervous system,” said Kåre Schultz, President and CEO
of Teva. “The approval of AJOVY helps us to continue to provide
access to important medicines and to deliver on our commitment to
our key stakeholders – patients, employees and shareholders.”
“With limited availability of preventive treatment options,
AJOVY provides physicians with an important new option for their
patients,” said Hafrun Fridriksdottir, Executive Vice President,
Global R&D at Teva. “This approval furthers our ongoing
commitment and experience in neurological conditions like
migraine.”
The U.S. Wholesale Acquisition Cost (WAC) of AJOVY is $575 per
monthly dose and $1,725 per quarterly dose. AJOVY will be available
through retail and specialty pharmacies in approximately two weeks.
There is a savings offer for AJOVY. Commercially insured patients
may pay as little as $0 on prescriptions for AJOVY until the offer
expires. Teva Shared Solutions® is available to provide support
services for patients and offices. Visit AJOVY.com to learn
more.
“Today’s approval is an important step forward for Teva and the
migraine community,” said Brendan O’Grady, Executive Vice President
and Head of North America Commercial at Teva. “Our entire
organization is proud to bring this new biologic product forward at
a responsible price, and we are eager to work with insurers to
encourage coverage that provides full access and availability in
this much needed category.”
About AJOVYTM
AJOVY is indicated for the preventive treatment of migraine in
adults. 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 office by a healthcare professional or
at home by a patient or caregiver. No starting dose is required to
begin treatment.
IMPORTANT SAFETY INFORMATION
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 Prescribing Information for AJOVYTM
(fremanezumab-vfrm) injection.
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 45,000
professionals, committed to improving the lives of millions of
patients. 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 the approval of AJOVYTM, 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 AJOVYTM, including the expected launch of the product;
- 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; 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 substantially increased
indebtedness and significantly decreased cash on hand, which may
limit our ability to incur additional indebtedness, engage in
additional transactions or make new investments, and 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 the 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 sales 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, 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
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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Teva Pharmaceutical Industries Ltd.IR ContactsKevin C.
Mannix, 215-591-8912orRan Meir, 972 (3) 926-7516orPR
ContactsUnited StatesDoris Saltkill,
913-777-3343orIsraelYonatan Beker, 972 (54) 888 5898
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