Teva to Present New Data on AJOVY® (fremanezumab-vfrm) Injection Open-Label Extension Study at American Headache Society Ann...
2020年6月15日 - 9:00PM
ビジネスワイヤ(英語)
Teva Pharmaceuticals USA, Inc., an affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced 24 abstracts featuring data on AJOVY® (fremanezumab-vfrm)
injection will be presented at the American Headache Society (AHS)
Virtual Annual Scientific Meeting which began June 13. AJOVY,
indicated for the preventive treatment of migraine in adults, is
the only long-acting anti-CGRP subcutaneous injection with the
option of dosing only four times per year.i*+
The data presented at AHS will focus on disability,
quality-of-life and work productivity during the 12-week open label
extension of the FOCUS Phase IIIb clinical trial, which evaluated
AJOVY in adult patients with migraine and documented inadequate
response to 2-4 classes of prior preventive treatments. Additional
abstracts examine disability outcome measurements from pooled
analyses of three AJOVY Phase III trials – FOCUS, HALO-Episodic
Migraine, and HALO-Chronic Migraine.
“Migraine is the second leading cause of years lived with
disability and imposes physical, emotional, and societal burdens
worldwide,” said Denisa Hurtukova, MD, Vice President, Head of
North America Medical Affairs. “We are committed to advancing the
understanding of the AJOVY patient experience by continuing to
examine patients with difficult-to-treat migraine.”
All presentations can be accessed through the AHS website.
The full list of Teva abstracts being presented includes:
FOCUS Study Including Open-Label
Extension
Disability, Quality of Life, Patient Satisfaction &
Depression
- Health-Related Quality of Life Outcomes With Fremanezumab in
Patients With Episodic and Chronic Migraine and Documented
Inadequate Response to 2-4 Classes of Migraine Preventive
Medication: Open-label Extension of the FOCUS Phase 3b Study
- Work Productivity and Activity Impairment Outcome With
Fremanezumab in Patients With Episodic and Chronic Migraine and
Documented Inadequate Response to 2-4 Classes of Migraine
Preventive Medications: Open-label Extension of the Phase 3b FOCUS
Study
- Patient Satisfaction With Fremanezumab During the Open-label
Period of the Phase 3b FOCUS Study in Patients With Episodic and
Chronic Migraine and Documented Inadequate Response to 2-4 Classes
of Migraine Preventive Medications
- Effect of Fremanezumab on Depression Status in Patients With
Episodic and Chronic Migraine and Documented Inadequate Response to
2-4 Classes of Migraine Preventive Medications During the
Open-label Period of the Phase 3b FOCUS Study
- Impact of Fremanezumab on Headache-related Disability in
Patients With Migraine Who Failed 2-4 Classes of Preventive
Medication: Results of the Open–label Extension of the Phase 3b
FOCUS Study
- Impact of Fremanezumab on Migraine-specific Quality of Life in
Patients With Medication Overuse and Documented Inadequate Response
to 2-4 Migraine Preventive Medication Classes in the FOCUS
Study
Efficacy and Safety
- Efficacy of Fremanezumab by Prior Number of Preventive
Treatments With Inadequate Response in Patients With Episodic
Migraine and Chronic Migraine: Results of the International,
Multicenter Phase 3b FOCUS Study
- Efficacy and Safety of Fremanezumab in Patients With Episodic
and Chronic Migraine and Inadequate Response to 2-4 Classes of
Preventive Medications: Results of the Open-label Period of the
Phase 3b FOCUS Study
- Clinically Meaningful Responses to Fremanezumab in Patients
With Migraine Who Failed 2–4 Classes of Migraine Preventive
Medication: Results of the Open–label Period of the Phase 3b FOCUS
Study
- Impact of Fremanezumab on Migraine-associated Symptoms in
Patients With Migraine Who Failed 2-4 Classes of Preventive
Medications: Results of the Open-label Period of the Phase 3b FOCUS
Study
Subgroup Analyses
- Impact of Fremanezumab on Disability in Migraine Patients With
Medication Overuse and Documented Inadequate Response to 2-4
Classes of Preventive Treatments: Subgroup Analysis of the FOCUS
Study
- Efficacy of Fremanezumab in Male Patients With Migraine and
Documented Inadequate Response to 2-4 Classes of Migraine
Preventive Treatments: Results of the Randomized,
Placebo-controlled FOCUS Study
Pooled Phase III Results
- Impact of Fremanezumab on Disability Severity According to the
AHS Consensus: Pooled Results of 3 Randomized, Double-blind,
Placebo-controlled Phase 3 Studies
- Disability Severity Category Shift with Fremanezumab Treatment:
Pooled Results of 3 Randomized, Double-blind, Placebo-controlled
Phase 3 Studies
- Efficacy of Fremanezumab Treatment in Patients ≥60 Years of Age
With Episodic or Chronic Migraine: Pooled Results of 3 Randomized,
Double-blind, Placebo-controlled Phase 3 Studies
- Improvements in Headache-related Disability With Fremanezumab
in Patients ≥60 Years of Age With Migraine: Pooled Results of 3
Randomized, Double-blind, Placebo-controlled Phase 3 Studies
- Improvements in Quality-of-Life, Productivity, and Satisfaction
With Fremanezumab in Migraine Patients ≥60 Years of Age: Pooled
Results of 3 Randomised, Double-blind, Placebo-controlled Phase 3
Studies
- Pooled Analysis of Cardiovascular Safety With Fremanezumab
Treatment in Patients With Migraine by Number of Cardiovascular or
Cerebrovascular Risk Factors
- Pooled Analysis of Tolerability With Fremanezumab Treatment in
Patients With Episodic or Chronic Migraine and Cardiovascular
Medication Use at Baseline
- Pooled Analysis of Cardiovascular Safety With Fremanezumab
Treatment in Patients With Migraine and Concomitant Triptan
Use
Migraine & Headache Disease
State
- Depression and Migraine – a Double Whammy on Patient-reported
Health
- Narrative Review of Risk Factors and the Burden of Medication
Overuse Headache on Quality-of-life and Co-morbidities
Real-World Perspectives
- A Real-World Perspective of Patients With Episodic Migraine or
Chronic Migraine Prescribed AJOVY in the United States
Patient Characteristics
- Treatment Patterns and Characteristics of Patients Prescribed
AJOVY, Emgality, or Aimovig
About AJOVY® (fremanezumab-vfrm) injection
AJOVY is available as a 225 mg/1.5 mL 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), which is 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. The AJOVY autoinjector has been
approved by the FDA and is available in the U.S. In addition to the
U.S., the AJOVY autoinjector is currently available in Germany and
should soon be available in other select European markets.
U.S. Important Safety Information about AJOVY®
(fremanezumab-vfrm) injection
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 U.S. Prescribing Information for
AJOVY® (fremanezumab-vfrm) injection.
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
regarding AJOVY® (fremanezumab-vfrm) Injection, 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; the increase in the number of
competitors targeting generic opportunities and seeking U.S. market
exclusivity for generic versions of significant products;
competition for our specialty products, especially COPAXONE®, our
leading medicine, which faces competition from existing and
potential additional generic versions, competing glatiramer acetate
products and orally-administered alternatives; the uncertainty of
commercial success of AJOVY or AUSTEDO®; competition from companies
with greater resources and capabilities; delays in launches of new
products and our ability to achieve expected results from
investments in our product pipeline; ability to develop and
commercialize biopharmaceutical products; efforts of pharmaceutical
companies to limit the use of generics, including through
legislation and regulations and the effectiveness of our patents
and other measures to protect our intellectual property
rights;
- our business and operations in general, including: duration,
and geographic reach of the COVID-19 pandemic and its impact on our
business, financial condition, operations, cash flows, and
liquidity and on the economy in general; interruptions in our
supply chain, including due to potential effects of the COVID-19
pandemic on our operations and business in geographic locations
impacted by the pandemic and on the business operations of our
customers and suppliers; adequacy of and 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;
implementation of our restructuring plan announced in December
2017; challenges associated with conducting business globally,
including adverse effects of the COVID-19 pandemic, political or
economic instability, major hostilities or terrorism; our ability
to attract, hire and retain highly skilled personnel; our ability
to develop and commercialize additional pharmaceutical products;
compliance with anti-corruption sanctions and trade control laws;
manufacturing or quality control problems; disruptions of
information technology systems; breaches of our data security;
variations in intellectual property laws; 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; our prospects and
opportunities for growth if we sell assets and potential
difficulties related to the operation of our new global enterprise
resource planning (ERP) system;
- compliance, regulatory and litigation matters, including:
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications in the U.S. and our
ability to reach a final resolution of the remaining opioid-related
litigation; costs and delays resulting from the extensive
governmental regulation to which we are subject or delays in
governmental processing time including due to modified government
operations due to the COVID-19 pandemic and effects on product and
patent approvals; the effects of reforms in healthcare regulation
and reductions in pharmaceutical pricing, reimbursement and
coverage; governmental investigations into S&M 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 Quarterly Report on Form 10-Q
for the first quarter of 2020 and our Annual Report on Form 10-K
for the year ended December 31, 2019, 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.
i AJOVY(fremanezumab-vfrm) injection Current Prescribing
Information. North Wales, PA: Teva Pharmaceuticals USA, Inc.
* “Long-acting” defined as efficacy measured over a 12-week
period following a 675 mg (225 mg x 3) SC dose.i
+ 225 mg monthly administered as one subcutaneous injection, or
675 mg every three months (quarterly), which is administered as
three subcutaneous injections.
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