Analysis assessed migraine days at the
beginning and end of quarterly and monthly dosing intervals
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced results from a post hoc analysis of a long-term,
open-label extension study assessing migraine days at the beginning
and end of quarterly and monthly dosing intervals of AJOVY®
(fremanezumab-vfrm) injection. The results were published in the
October issue of Headache: The Journal of Head and Face Pain.
“We are proud to share this analysis and demonstrate our
continued commitment to advancing the understanding of treatment
options for patients living with migraine,” said Denisa Hurtukova,
MD, Vice President, Head of North America Medical Affairs, Teva.
“This analysis helps us better understand patients’ experience with
AJOVY, as well as the impact of quarterly and monthly dosing
options.”
The post hoc analysis compared migraine days in the initial and
final weeks of quarterly or monthly dosing regimens of AJOVY during
up to 15 months of treatment. The analysis included 1,043 patients
with chronic migraine (CM) (n=611) and episodic migraine (EM)
(n=432) who were initially enrolled in the pivotal placebo
controlled HALO CM and EM studies and then continued in the
long-term, 12-month, multicenter, randomized, parallel group Phase
3 study with double blind dosing regimens. Patients received AJOVY
either quarterly or monthly.
“Utilizing patients within each dosing group as their own
control, we were able to analyze whether there was variability in
migraine days over the course of a dosing regimen. For all time
intervals analyzed, the frequency of migraine days was the same in
the beginning and end of the dosing period,” said Joshua M. Cohen,
MD, MPH, FAHS, Global Medical Therapeutic Area Lead for Migraine
& Headache, Teva.
“This is an important analysis for the migraine community since
clinical symptoms often return or worsen before the next dose of
many preventive migraine medications is due,” said Andrew
Blumenfeld, MD, Headache Center of Southern California, The
Neurology Center, Carlsbad, CA. “Migraine can be a debilitating
disease, so evaluating migraine days throughout a dosing regimen
can be significant for healthcare providers when considering
treatment options. Whenever the brain is exposed to a migraine
attack, there is the possibility of increased sensitization with
progressive worsening of the frequency of migraine. A key clinical
goal is to limit the amount of time the brain is exposed to
migraine to reduce this risk and the number of migraine days
impacting a patient before their next dose.”
The mean weekly number of migraine days at baseline was 4.0 for
patients with CM taking quarterly or monthly AJOVY. For patients
with EM, the mean weekly number of migraine days at baseline in the
quarterly and monthly AJOVY groups were both 2.3 days.
The analysis found:
Mean number of weekly migraine
days in weeks 1-2 versus weeks 11-12 with quarterly dosing1*
First Quarter
Second Quarter
Weeks 1-2
Weeks 11-12
Weeks 1-2
Weeks 11-12
CM
2.8
2.7
2.5
2.5
EM
1.5
1.3
1.2
1.1
CM: n=348 first quarter, n=283 second
quarter; EM: n=262 first quarter, n=195 second quarter
Mean number of weekly migraine
days during weeks 1-3 versus week 4 at months 3, 6, 9 and 15 with
monthly dosing1*
Month 3
Month 6
Month 9
Month 15
Weeks 1-3
Week 4
Weeks 1-3
Week 4
Weeks 1-3
Week 4
Weeks 1-3
Week 4
CM
2.6
2.6
2.3
2.4
2.1
2.1
2.0
1.8
EM
1.2
1.2
1.0
1.0
1.0
1.0
0.8
1.0
CM: n=334 month 3, n=264 month 6, n=250
month 9, n=223 month 15; EM: n=251 month 3, n=191 month 6, n=180
month 9, n=155 month 15
For all post hoc analyses, no determination of statistical
significance can be made, and no conclusions should be drawn. No
new safety signals were identified in this population that were
inconsistent with the known safety profile of AJOVY.
AJOVY is the first and only long-acting anti-CGRP subcutaneous
injection approved in the US and EU for the preventive treatment of
migraine in adults that offers both quarterly and monthly dosing
options.2+±
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.
Information for Europe about AJOVY® can be found
here.
Adverse events should be reported.
This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
events.
Reporting forms and information can be found at
https://www.hpra.ie. Adverse events should also be reported to Teva
– please refer to local numbers.
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®, 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 commercial success of AJOVY;
- 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 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: uncertainty
regarding the magnitude, 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;
effectiveness 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: our
ability to successfully defend against the DOJ criminal charges of
a Sherman Act violations; 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 Reports on Form
10-Q for the first and second quarters 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.
1. Data on file. Parsippany, NJ: Teva Pharmaceuticals USA,
Inc.
2. AJOVY(fremanezumab-vfrm) injection Current Prescribing
Information. North Wales, PA: Teva Pharmaceuticals USA, Inc.
* Study design: Of the patients who rolled over from the HALO
studies, 611 from the HALO CM study (quarterly, n=306; monthly,
n=305) and 432 from the HALO EM study (quarterly, n=217; monthly,
n=215) had received AJOVY® (fremanezumab-vfrm) injection during the
respective HALO study and were included in post hoc analyses during
the long-term, open-label extension study1
+ “Long-acting” defined as efficacy measured over a 12-week
period following a 675 mg (225 mg x 3) SC dose.2
± 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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