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|October 17, 2017 8:01 a.m.|
|Teva Announces Submission of Biologics License Application for Fremanezumab to the U.S. FDA|
Key milestone reached for Teva to advance global fremanezumab program
for the preventive treatment
Fremanezumab aims to address unmet need in migraine community, a
disease with currently limited
“The BLA submission for fremanezumab marks a very important milestone
for the migraine community,” said
“Phase III clinical studies of fremanezumab demonstrated a significant
reduction in the number of migraine and headache days, acute medication
use and disability, in addition to demonstrating improvement in quality
of life in patients living with episodic and chronic migraine,” said
The BLA includes data from the HALO clinical trial program, which
enrolled more than 2,000 patients with episodic migraine (EM) and
chronic migraine (CM), evaluating both monthly and quarterly dose
regimens of fremanezumab. Results from these trials were recently
presented at the
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).
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% 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 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.