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|February 02, 2018 7:00 a.m.|
|European Medicines Agency (EMA) Accepts Fremanezumab Marketing Authorization Application|
Teva seeking EU regulatory approval for anti-CGRP therapy for the prevention of migraine
“The successful filing of the MAA for fremanezumab with the EMA builds
on the momentum of the global fremanezumab program, following acceptance
of the Biologics License Application with the
The MAA 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 quarterly and monthly dosing regimens, in which fremanezumab achieved statistically significant results across all trial endpoints. The most common adverse events reported in clinical trials include injection site pain, induration, and erythema.
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).
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.
Fremanezumab is also being investigated for the prevention of chronic
and episodic cluster headache as part of the Phase III ENFORCE clinical
research program, which has been granted fast track designation by the
Migraine is an unpredictable neurological disease 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 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 Fremanezumab Marketing Authorization Application, 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.