Findings describe the efficacy and safety results of clinical trials
of fremanezumab through 12 months of treatment in patients with chronic
and episodic migraine
JERUSALEM–(BUSINESS WIRE)–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 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: failure to
effectively execute our restructuring plan announced in December 2017;
uncertainties related to, and failure to achieve, the potential
benefits and success of our new senior management team and
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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 acquisitions; and our
prospects and opportunities for growth if we sell assets ; -
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governmental investigations into selling and marketing practices;
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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 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.
Contacts
IR Contacts
United States
Kevin C. Mannix, (215)
591-8912
Ran Meir, 972 (3) 926-7516
PR Contacts
United States
Doris Saltkill, (913)
777-3343
Israel
Yonatan Beker, 972 (54) 888 5898