Open-label extension of the FOCUS Phase IIIb
study examined changes in quality of life, health status,
depressive symptoms and work productivity over 12 weeks
Pooled Phase 3 results examined changes in
disability using American Headache Society guidelines
Teva Pharmaceuticals USA, Inc., an affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced new data examining quality of life, health status,
depressive symptoms, work productivity and activity impairment of
patients treated with AJOVY during the 12-week open-label extension
of the Phase IIIb FOCUS study. An additional analysis of pooled
results from three AJOVY Phase III trials (FOCUS, HALO-Episodic
Migraine, HALO-Chronic Migraine) examined headache- and
migraine-related disability based on guidelines set forth by the
American Headache Society (AHS). The data were presented at the AHS
Virtual Annual Scientific Meeting.
“Migraine is more than just a headache and profoundly disrupts
all aspects of life, including family life, social interactions and
workplace success,” said Denisa Hurtukova, MD, Vice President, Head
of North America Medical Affairs. “It is critical that we take
these aspects into consideration when developing a treatment plan
and these new AJOVY data broaden our understanding of overall
quality of life. Teva is committed to ongoing evaluations of AJOVY
and supports clinically meaningful guidelines set forth by the AHS
and other professional organizations.”
Quality of Life, Health Status, Depressive Symptoms and Work
Productivity in the FOCUS Phase IIIb Open-Label Extension
The FOCUS Phase IIIb open-label extension examined quality of
life, health status, depressive symptoms and work productivity
observed over an additional 12 weeks of treatment with AJOVY. FOCUS
evaluated quarterly and monthly treatment with AJOVY compared to
placebo in adult patients with migraine and documented inadequate
response to 2-4 classes of prior preventive treatments. All
patients completing double-blind treatment entered the 12-week
open-label extension and received a monthly dose of AJOVY (225 mg)
for three months (n=772).
The following results were observed in quality of life, health
status, depressive symptoms, and work productivity based on scores
from validated patient-reported questionnaires, including
Migraine-Specific Quality of Life (MSQOL), 5-level EuroQol-5
Dimension (EQ-5D-5L), Patient Global Impression of Change (PGIC),
9-item Patient Health Questionnaire (PHQ-9), and Work Productivity
and Activity Impairment (WPAI) questionnaire:
- MSQoL quality-of-life domain scores and the EQ-5D-5L health
status score at the end of the double-blind period (change from
baseline: MSQoL, 11.9 to 17.5 points; EQ-5D-5L, 4.7 to 7.2 points)
and through the end of the open-label extension (change from
baseline: MSQoL, 18.3 to 24.6 points; EQ-5D-5L, 7.3 to 8.0
points).
- The proportion of patients who experienced a response on the
PGIC (rating of moderate to a great deal better) increased from 58%
to 64% at the end of the double-blind period to 75% to 77% at the
end of the open-label extension.
- Depressive symptom scores (based on the PHQ-9) were reduced by
1.6 to 2.4 points by the end of the open-label extension.
- 14.5% to 20% reductions from baseline were reported in overall
health-related work impairment by the end of the open-label
extension.
Additionally, the safety and tolerability of AJOVY during this
open-label extension was evaluated, with the most common adverse
events (AEs) being injection-site reactions, such as injection-site
erythema (6%). The reports of AEs leading to discontinuation were
<1% and 3% for serious AEs.
Disability Severity According to the AHS Consensus
The AHS Consensus Statement provides guidelines on determining
response to CGRP pathway targeted treatments for migraine. As
changes in migraine frequency may not adequately assess treatment
benefit in all patients, these guidelines recommended specific
improvements in disability scores on the MIDAS and HIT-6 that would
be considered clinically meaningful and evidence of response to
treatment. The disability in patients treated with AJOVY (HIT-6
n=1,958; MIDAS n=1,702) was evaluated using pooled data from the
three double-blind Phase III trials.
A post-hoc analysis of the pooled Phase III study data based on
guidelines set forth by the Consensus Statement noted AJOVY
patients experiencing severe disability due to migraine at baseline
achieved the following disability score reductions:
- For patients with a baseline MIDAS score of 11-20, the
proportion of patients achieving a 5-point reduction from their
baseline score was 71% (quarterly) and 70% (monthly) with AJOVY and
49% with placebo.
- The proportion of patients with a baseline MIDAS score of
>20 who achieved a ≥30% reduction in points was 69% (quarterly)
and 79% (monthly) with AJOVY and 58% with placebo.
- The proportion of patients achieving a 5-point reduction from
baseline in HIT-6 scores was 53% (quarterly) and 55% (monthly) with
AJOVY and 39% with placebo.
The complete data sets and full presentations can be accessed
through the AHS website.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200618005205/en/
IR Contacts United States Kevin C. Mannix (215)
591-8912
Ran Meir 972 (3) 926-7516
PR Contacts United States Doris Li (973) 265-3752
Israel Yonatan Beker 972 (54) 888 5898
Teva Pharmaceutical Indu... (NYSE:TEVA)
過去 株価チャート
から 6 2024 まで 7 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
過去 株価チャート
から 7 2023 まで 7 2024