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|May 31, 2017 8:23 a.m.|
|Teva Announces Positive Results for Phase III Study of Fremanezumab for the Prevention of Chronic Migraine|
Chronic migraine study met all primary and secondary endpoints in both monthly and quarterly dosing regimens
In addition, patients treated with fremanezumab experienced significant improvement compared to placebo on all secondary endpoints for both monthly and quarterly dosing regimens, including: response rate, onset of efficacy, efficacy as monotherapy, and disability. The results were positive, and of 13 hierarchical comparisons, p was <0.0001 in 12 of them, being 0.0004 in the remaining. The most commonly-reported adverse event in the study was injection site pain, with similar rates in the placebo and active groups.
“Migraine is a serious, debilitating neurological condition that
substantially impacts all aspects of a person’s life,” said
“These top-line results reflect our differentiated clinical development
program and add to a growing body of evidence that supports the
development of CGRP targeted therapy in migraine, including patients
with very severe forms of the disease, with flexible dosing regimens,”
said Marcelo Bigal, M.D., Ph.D., Chief Medical Officer & Head of
“We are excited about our development progress and look forward to
sharing more detailed results with the migraine community at future
scientific conferences,” said
Based on these results, Teva plans to submit a Biologics License
Application to the U.S. Food and Drug Administration (
About the HALO Clinical Research Program
The Phase III HALO EM and CM studies are 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 consist 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).
In the CM study, 1,130 patients were randomized (around 376 patients per treatment group). Patients were randomized in a 1:1:1 ratio to receive subcutaneous injections of fremanezumab at 675 mg at initiation followed by monthly 225 mg for two months (monthly dose regimen), fremanezumab at 675 mg at initiation followed by placebo for two months (quarterly dose regimen), or three monthly doses of matching placebo. The primary efficacy endpoint of the CM study was the mean change from baseline (28-day run-in period) in the monthly average number of headache days of at least moderate severity during the 12-week period after the first dose of fremanezumab.
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. With
more than 1 billion people affected worldwide, migraine is the third
most prevalent illness in the world. More than 38 million Americans have
migraine. Of the approximately 40% of patients suffering from migraine
for whom prevention is appropriate, only 13% are currently receiving
therapy. According to the
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 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:
and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”), including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. 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.
Teva Pharmaceutical Industries Ltd.