Findings describe the efficacy and safety
results of clinical trials of fremanezumab through 12 months of
treatment in patients with chronic and episodic migraine
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced results from new long-term analyses of the efficacy and
safety of fremanezumab, being presented at the 71st Annual Meeting
of the American Academy of Neurology (AAN) in Philadelphia from May
4-10, 2019.
The findings, presented across 13 abstracts at this year’s
meeting, describe the primary and other key endpoints, as well as
pooled and subgroup data from a 52-week, multicenter, randomized,
double-blind, parallel group long-term extension study that
evaluated fremanezumab in adults with migraine. The results
presented include data on the efficacy of fremanezumab observed
through 12 months of treatment in patients with migraine, including
populations with inadequate responses to multiple classes of
preventive medications, quality of life and the safety profile.
“We are pleased to join the neurology community at this year’s
AAN meeting and share these long-term data results on fremanezumab
as a preventive treatment option for patients living with
migraine,” said Danny McBryan, Senior Vice President, Head of
Global Medical Affairs and Pharmacovigilance at Teva. “These data,
studied in a wide range of migraine patient populations, add to our
growing body of evidence about fremanezumab, and further
demonstrate our ongoing commitment to improving the lives of those
who suffer from migraine.”
Analysis design
The long-term extension study of fremanezumab included patients
rolled over from two placebo-controlled studies, as well as 312
newly enrolled patients. Patients were assigned to either monthly
dosing (225 mg monthly; chronic migraine: starting dose of 675 mg),
or quarterly dosing (675 mg every three months). A total of 1,890
patients were enrolled and 1,494 completed 12 months of treatment.
Patients included those with chronic migraine (CM) and episodic
migraine (EM).
Analysis highlights
A selection of key data points of note across the analyses are
summarized below.
Long-term efficacy and safety results:
- In an analysis of the 1,110 patients
included in the study with CM, those achieving ≥50 percent
reduction in monthly average number of headache days of at least
moderate severity at month 12 was 54 percent of patients in the
quarterly dosing arm and 59 percent in the monthly dosing arm.
Those achieving ≥50 percent reduction in monthly average number of
migraine days at month 12 was 53 percent of patients in the
quarterly dosing arm and 57 percent of patients in the monthly
dosing arm. Additionally, patients with CM showed decreased use of
any acute headache medication and improvements in disability that
were observed through the one-year treatment period.1
- An analysis of the 780 patients
included in the study with EM demonstrated that patients achieving
≥50 percent reduction in migraine days at month 12 was 66 percent
in the quarterly dosing arm and 68 percent in the monthly dosing
arm. Similar response rates were observed for headache days of at
least moderate severity. Similar to the results observed in CM
patients, patients with EM also showed decreased use of any acute
headache medication and improvements in disability that were
observed through the one-year treatment period.2
- Additionally, Teva conducted a post-hoc
efficacy analysis of 813 patients with CM at baseline, of which 67
percent (548) reverted to EM during the study period. In this
subgroup, the average change in the monthly number of headache days
of at least moderate severity from baseline to month 12 was -8.8
for the quarterly dosing arm and -8.5 for the monthly dosing arm.
The mean change in the monthly number of migraine days from
baseline to month 12 was -10.3 for quarterly and -10.4 for monthly.
Overall, monthly headache days, migraine days and days of acute
headache medication use decreased progressively from month six and
through month 12 in both dosing groups.3
- A safety analysis of all 1,890 patients
enrolled in the one-year study demonstrated that the most common
adverse events (AEs) were injection-site reactions, which occurred
in 26-33 percent of all patients. Four percent of patients
discontinued due to adverse events.4
Quarterly dosing persistency results:
- Teva also assessed whether patients in
the quarterly dosing arm experienced any pattern of decreased
efficacy during the third month after injection (also known as
“wearing off” effect). In the analysis of 1,103 CM patients and 775
EM patients, outcomes with quarterly dosing of fremanezumab were
comparable to outcomes with monthly dosing.5
Quality of life results:
- The effect of fremanezumab on
headache-related disability, quality-of-life and patient
satisfaction in CM and EM patients was assessed using clinically
validated questionnaires. Overall, long-term treatment with
fremanezumab suggested potential improvements in disability and
quality of life in patients with both CM and EM.6
About fremanezumab
AJOVY® (fremanezumab-vfrm) injection is indicated for the
preventive treatment of migraine in adults.
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 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 35,000
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, 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; competition for our specialty products,
especially COPAXONE®, our leading medicine, which faces competition
from existing and potential additional generic versions and
orally-administered alternatives; the uncertainty of commercial
success of AJOVY® and AUSTEDO®; 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
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- our substantial indebtedness, which may
limit our ability to incur additional indebtedness, engage in
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further downgrade of our credit ratings; and our inability to raise
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including: failure to effectively execute our restructuring plan
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following our resolution with the U.S. government of our FCPA
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our ability to manufacture our products; challenges associated with
conducting business globally, including adverse effects of
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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
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- compliance, regulatory and litigation
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pricing, reimbursement and coverage; governmental investigations
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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, 2018, including the sections
thereof captioned "Risk Factors." 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:1Mcallister P, et al.
Long-Term Impact of Fremanezumab on Response Rates, Acute Headache
Medication Use, and Disability in Patients With Chronic Migraine:
Results of a 1-Year Study. Presented at: 2019 AAN Annual Meeting,
Philadelphia, PA.2Brandes JL, et al. Long-Term Impact of
Fremanezumab on Response Rates, Acute Headache Medication Use, and
Disability in Patients With Episodic Migraine: Results of a 1-Year
Study. Presented at: 2019 AAN Annual Meeting, Philadelphia,
PA.3Lipton R, et al. Long-Term Efficacy of Fremanezumab in Patients
Who Reverted From a Chronic to an Episodic Migraine Classification.
Presented at: 2019 AAN Annual Meeting, Philadelphia, PA.4Ning X, et
al. Long-Term Safety of Fremanezumab: Results of a 1-Year Study.
Presented at: 2019 AAN Annual Meeting, Philadelphia, PA.5Blaise CA,
et al. Quarterly Administration of Fremanezumab Does Not Show
“Wearing Off” Effect During Third Month After Injection. Presented
at: 2019 AAN Annual Meeting, Philadelphia, PA.6Cohen J, et al.
Long-Term Impact of Fremanezumab on Headache-Related Disability,
Quality of Life, and Patient Satisfaction in Episodic Migraine and
Chronic Migraine Presented at: 2019 AAN Annual Meeting,
Philadelphia, PA.
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IR ContactsUnited StatesKevin C. Mannix, (215)
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