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|September 09, 2017 8:00 a.m.|
|Teva Showcases Data Demonstrating Potential of Fremanezumab to Address Significant Unmet Need in Patients with Chronic and Episodic Migraine|
Late-Breaking Data Presented at IHC Highlight Primary and Secondary Outcome Measure Results from Chronic and Episodic Migraine Phase III Clinical Trials
“We developed a clinical program for fremanezumab that was
patient-centered, and closely mimicked the real-world experience of
people living with the debilitating effects of migraine,” said
“The statistically significant results from the CM and EM trials across
multiple measures of migraine burden, including improvement in quality
of life and disability, highlight the potential of fremanezumab to
provide patients with meaningful relief,” said Marcelo Bigal, M.D.,
Ph.D., Chief Medical Officer & Head of
Across the Phase III HALO studies in chronic and episodic migraine, fremanezumab achieved statistically significant and clinically meaningful results for all 25 primary and secondary analyses in both monthly and quarterly dosing regimens. In the chronic migraine study, endpoint analyses presented at IHC include:
In episodic migraine, endpoint analyses presented at IHC include:
The most commonly-reported adverse event in the episodic and chronic migraine trials was injection site pain, with similar rates in the placebo and active groups.
“The results we have presented at IHC are truly exciting and reflect
Teva’s commitment to developing and delivering medicines to meet the
needs of patients around the world living with chronic diseases,” said
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.
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).
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% 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.