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|June 07, 2017 8:00 a.m.|
|Teva's Fremanezumab Meets all Primary & Secondary Endpoints Across Both Monthly and Quarterly Dosing Regimens in Phase III Study in Episodic Migraine Prevention|
Statistically and clinically significant results demonstrate fremanezumab's efficacy and safety, including unique quarterly subcutaneous dosing regimen, and in patients already on preventive therapy
Follows positive results in chronic migraine announced by Teva last week, together representing major advance in the development of new treatment options for the millions of patients who suffer from this debilitating disease
Teva’s Phase III HALO program now complete, encompassing more than 2000 patients, meeting all 25 primary and secondary analyses across both monthly and quarterly dosing regimens in episodic and chronic migraine studies
Participants in this trial had a mean of 9.1 migraine days per month and reported 39 days with functional impairment per quarter. In this severely affected population, Fremanezumab given monthly improved the average number of migraine days, relative to baseline, by 41.6% for the duration of the trial (-3.7 days vs. -2.2 days for placebo, p < 0.0001). Number of days with disability were decreased by 64.7% (p =0.0021) and medication consumption was decreased by 39.0%( p < 0.0001). The quarterly SC dose, which was uniquely tested in this program, also yielded highly significant results for decrease in migraine days (-3.4 days or 37.0%, p < 0.0001) and for all other comparisons. Also unique to this development, both dose regimens highly significantly improved migraine in subjects on stable doses of other prophylactic medications (-4.0 days for monthly dose vs -2.0 days for placebo, p = 0.001; -3.7 days for quarterly dose, p = 0.006).
All other pre-specified analyses were met and were highly statistically significant. The most commonly-reported adverse event in the study was injection site pain, with similar rates in the placebo and active groups.
“This is an extremely important development for Teva in our desire to
make a meaningful difference to the millions of patients who suffer from
migraine around the world,” said Dr.
“Teva’s HALO trials are the only Phase III anti-CGRP studies to
demonstrate efficacy with both monthly and quarterly dosing for chronic
and episodic patients and in patients already receiving prevention
therapies. This is a major advance on existing data. The efficacy and
rapid onset, as both add-on and monotherapy, quarterly dosing, and
effect on disability and quality of life indicate that this therapy has
the potential to set new and different benchmarks in the relief of
migraine suffering," said
With topline readout of pivotal trials for fremanezumab in both episodic
and chronic migraine complete, Teva is conducting full analysis across
all endpoints with plans to present more detailed findings in
peer-reviewed publications and at future scientific congresses. This
includes results from the pivotal trial in chronic migraine at the
The data in this size of population of challenging patients, and the
meeting of all 25 endpoints and analyses is unmatched in this field.
Based on these results, Teva plans to submit a Biologics License
Application to the
"The terrible impact of migraine is often not fully recognized across
the world," said Marcelo Bigal, M.D., Ph.D., Chief Medical Officer and
About the HALO Clinical Research Program
The Phase III HALO EM and CM studies were 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies to compare the safety, tolerability, and efficacy of four dose regimens of subcutaneous fremanezumab compared to placebo in adults with episodic and chronic migraine. The studies consisted of a screening visit, a 28-day run-in period, and a 12-week (84-day) treatment period, including a final evaluation at week 12 (end-of-treatment [EOT] visit, four weeks [28 days] after the final dose of study drug). More than 2,000 patients received at least one dose of fremanezumab in the HALO clinical program, the largest of any of the anti-CGRP compounds.
In the EM study, 873 patients were enrolled (256 per treatment group). Patients were randomized in a 1:1:1 ratio to receive subcutaneous injections of fremanezumab at 225 mg as a monthly dose for three months, fremanezumab at 675 mg at initiation followed by placebo for two months, or three monthly doses of matching placebo. The primary efficacy endpoint of the EM study was the mean change from baseline (28-day run-in period) in the monthly average number of migraine days during the 12-week period after the first dose of fremanezumab. Similar to the Phase II trials, both patients that were on monotherapy and stable doses of prophylactic medications were included in the trial.
About Fremanezumab (TEV-48125)
Fremanezumab is a fully-humanized monoclonal antibody targeting the CGRP ligand, a well-validated target in migraine. With limited availability of preventive treatment options, fremanezumab represents a potential new option to address a significant unmet medical need.
Migraine is an unpredictable neurological condition with symptoms such as severe head pain and physical impairment that can impact quality of life and productivity. There are two clinical manifestations of migraine – chronic, where patients suffer 15 or more headache days per month, and episodic, where patients have 14 or less headache days per month. Worldwide, approximately 90 percent of people diagnosed with migraine have episodic migraine and 10 percent have chronic migraine.
With more than 1 billion people affected worldwide, migraine is the
third most prevalent illness in the world and the 6th most disabling
illness in the world. In the U.S., EU5 and
Cautionary Statements Regarding Forward-Looking Information:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the potential benefits and commercialization of Fremanezumab, 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:
Teva Pharmaceutical Industries Ltd.