Findings describe long-term and real-world data
across post-hoc and retrospective analyses
Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today
announced new data from clinical and real-world analyses examining
the efficacy of AJOVY® (fremanezumab-vfrm). These data are being
presented at the 2021 American Academy of Neurology (AAN) Virtual
Annual Meeting, taking place April 17-22.
The data being presented at the meeting span 17 posters and
include post-hoc Phase 3 data examining the long-term response of
AJOVY in patients who initially did not respond to treatment, an
analysis of real-world treatment patterns for patients prescribed
AJOVY, and a retrospective evaluation of quarterly and monthly
dosing with AJOVY in a real-world setting.
“In addition to our continued work evaluating Phase 3 AJOVY
data, we now look forward to studying AJOVY in a real-world setting
using patient data and outcomes to help validate our clinical trial
findings and advance the AJOVY patient experience,” said Denisa
Hurtukova, MD, VP, Head of North America Medical Affairs. “The data
presented at AAN provide valuable insights into the long-term use
of AJOVY in both clinical and real-world settings, giving the
migraine community valuable information and a broader understanding
of the potential efficacy of ongoing treatment.”
AJOVY is the first and only long-acting anti-CGRP subcutaneous
injection approved in the US for the preventive treatment of
migraine in adults that offers both quarterly and monthly dosing
options.1+±
Post Hoc Analysis Examines Long-Term Efficacy of AJOVY in
Patients Who Initially Responded Inadequately
Patients who completed the Phase 3 HALO Episodic Migraine (EM)
and Chronic Migraine (CM) clinical trial, along with new patients,
entered the HALO long-term study. Quarterly and monthly doses of
fremanezumab were maintained and newly-enrolled and placebo
patients were randomized one-to-one to receive quarterly or monthly
doses of fremanezumab. Of the 1,890 patients in the long-term
study, 210 were characterized as inadequate responders, defined by
<25 percent reduction in monthly migraine days at three months.
Across four subgroups defined by baseline migraine days,
approximately 50 percent of patients achieved a 50 percent
reduction in moderate to severe headache days at month 15, despite
an initial inadequate response.
This poster, Long-term Efficacy of Fremanezumab in Patients with
Chronic or Episodic Migraine Who Were Inadequate Responders to
Initial Fremanezumab Treatment, is poster P10.023 in the online
program.
Retrospective Analyses Evaluate Efficacy of Quarterly and
Monthly AJOVY Doses and Changes in Acute Medication Use
A retrospective, panel-based review of 1,003 patient charts from
421 physicians examined the effectiveness of quarterly and monthly
doses of fremanezumab for reducing monthly migraine days and
monthly headache days in adult migraine patients over a six-month
time period. Of the 1,003 patients, 381 received quarterly dosing
and 622 received monthly dosing. Baseline monthly migraine days
were 11.9 (quarterly) and 13.2 (monthly) and baseline monthly
headache days were 12.9 (quarterly) and 14.8 (monthly) (both
P≤0.002). Data from the patients’ charts supported both doses of
fremanezumab being effective for providing sustained and clinically
meaningful reductions in monthly headache days and monthly migraine
days over a six-month time period. Changes from baseline in monthly
migraine days did not differ significantly for quarterly versus
monthly dosing.
Month 1
Month 3
Month 6
Quarterly
Monthly
Quarterly
Monthly
Quarterly
Monthly
Mean (percent)
reductions
-3.9
[32.8%]
-4.9
[37.1%]
–6.2
[52.1%]
–7.2
[54.5%]
–9.5
[79.8%]
–8.9
[67.4%]
Monthly
headache days
-3.7
[28.7%]
-5.1
[34.5%]
–6.0
[46.5%]
–7.7
[52.0%]
–9.7
[75.2%]
-9.8
[66.2%])
In a separate evaluation, the IBM/MarketScan Early View
Commercial and Medicare database was used to identify adult
patients with at least one pharmacy claim for fremanezumab between
October 1, 2018 and March 31, 2019 to evaluate real-world clinical
characteristics and treatment patterns for patients with EM or CM
that may help inform treatment-related decisions. The evaluation
found that of the 1,225 patients identified, 93 percent were using
migraine-related prescription acute medications during the
pre-index period versus 88 percent during the post-index period.
Additionally, 69 percent versus 58 percent were using triptans and
30 percent versus 26 percent were using opioids during these time
periods (P<0.05 for pre-index versus post-index). The mean +/-
standard deviation of annual claims decreased from 9.8 +/- 9.5 to
8.0 +/- 8.6 for migraine-related prescription acute medications
during the pre-index to post-index period. This includes a decrease
from 4.3 +/- 5.2 to 3.1 +/- 4.3 for triptans during this time.
Evaluating these claims offers real-word evidence of fremanezumab
being associated with statistically significant reductions in acute
medication claims and good treatment adherence in the first 12
months of use.
These posters, US Real-world Effectiveness of Quarterly and
Monthly Fremanezumab for Reducing Migraine Days and Headache Days
in Adult Patients with Migraine, and US Real-World Patient
Characteristics, Acute Medication Use, and Treatment Patterns for
Patients Initiating Fremanezumab, are posters P10.031 and P10.088,
respectively, in the online program.
Retrospective Review Evaluates Real-World Adherence,
Persistence, Switching, and Reinitiation by Quarterly and Monthly
Dosing Regimen in Patients Prescribed AJOVY in US Physician
Practices
A retrospective review of real-world data obtained from the
Veradigm Health Insights Database examined treatment adherence and
persistence for patients prescribed quarterly versus monthly
dosing. Patients were included if they were ≥18 years; had ≥1
migraine diagnosis during the study period from January 1,
2014-June 30, 2019; and had a medication record for AJOVY on or
after diagnosis during the identification period (September 1,
2018–December 31, 2018). The following outcomes were recorded:
- Patients prescribed quarterly dosing were more likely to be
adherent based on proportion of days covered ≥80% (82.8% vs 72.9%
monthly; P=0.005) and medication possession ratio ≥80% (84.4% vs
77.8% monthly; P=0.045).
- Patients prescribed quarterly dosing were more likely to be
persistent for ≥6 months (82.8% vs 73.9% monthly; P=0.011) and less
likely to discontinue AJOVY (15.6% vs 23.4% monthly, P=0.021).
- Of patients discontinuing AJOVY, there was no significant
difference between quarterly and monthly dosing in proportions
switching to other acute/preventive migraine medications (44.8% vs
44.4%), reinitiating AJOVY (6.9% vs. 10.2%) or permanently
discontinuing all migraine medications (48.3% vs 47.6%; all
P>0.05).
This real-world study showed treatment adherence and persistence
were higher for patients prescribed quarterly versus monthly
dosing, with comparable switching and reinitiation rates.
This poster, Real-World Adherence, Persistence, Switching, and
Reinitiation by Quarterly and Monthly Dosing Regimen in Patients
Prescribed AJOVY in US Physician Practices, is poster P10.123 in
the online program.
This year’s annual AAN meeting is fully virtual. Data
presentations can be accessed by registering for the meeting.
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, 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; delays in launches of new generic
products; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; our ability to develop
and commercialize biopharmaceutical products; competition for our
specialty products, including AUSTEDO®, AJOVY and COPAXONE®; our
ability to achieve expected results from investments in our product
pipeline; our ability to develop and commercialize additional
pharmaceutical products; 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; 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 optimization efforts; our ability
to attract, hire and retain highly skilled personnel; manufacturing
or quality control problems; interruptions in our supply chain;
disruptions of information technology systems; breaches of our data
security; variations in intellectual property laws; challenges
associated with conducting business globally, including political
or economic instability, major hostilities or terrorism; costs and
delays resulting from the extensive pharmaceutical regulation to
which we are subject or delays in governmental processing time due
to travel and work restrictions caused by the COVID-19 pandemic;
the effects of reforms in healthcare regulation and reductions in
pharmaceutical pricing, reimbursement and coverage; 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; and our prospects and
opportunities for growth if we sell assets;
- compliance, regulatory and litigation matters, including:
failure to comply with complex legal and regulatory environments;
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications and our ability to
reach a final resolution of the remaining opioid-related
litigation; scrutiny from competition and pricing authorities
around the world, including our ability to successfully defend
against the U.S. Department of Justice criminal charges of Sherman
Act violations; potential liability for patent infringement;
product liability claims; failure to comply with complex Medicare
and Medicaid reporting and payment obligations; compliance with
anti-corruption sanctions and trade control laws; 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 this press release and in our
Annual Report on Form 10-K for the year ended December 31, 2020,
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.
References
- AJOVY® (fremanezumab-vfrm) injection, for subcutaneous use
[prescribing information]. Teva Pharmaceuticals USA, Inc.: North
Wales, PA; 2020. + “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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IR Contacts United States Kevin C. Mannix (215)
591-8912
Israel Yael Ashman 972 (3) 914-8262
PR Contacts United States Doris Li (973)
265-3752
Israel Yonatan Beker 972 (54) 888 5898
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