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|November 29, 2017 5:07 p.m.|
|The New England Journal of Medicine Publishes Data from Pivotal Phase III Trial of Fremanezumab for the Preventive Treatment of Chronic Migraine|
Marks the first Phase III chronic migraine data to be published within anti-CGRP class
“The burden of illness faced by those with migraine is immense and can
negatively impact every facet of their lives underscoring a significant
unmet need for new preventive treatment options,” said Stephen D.
Silberstein, M.D., Principal Investigator of the HALO trial, Professor
of Neurology and Director of the Jefferson Headache Center at
“We are very proud that the fremanezumab chronic migraine results are
the first Phase III CM anti-CGRP therapy data published, especially in
such a prestigious and well-renowned peer-reviewed journal,” said
The article, “Fremanezumab for the Preventive Treatment of Chronic
Migraine,” reports results of a multicenter, randomized, double-blind,
placebo-controlled, parallel-group Phase III study that evaluated
monthly and quarterly doses of fremanezumab versus placebo for the
preventive treatment of chronic migraine in 1,130 patients. These
findings, along with findings from the HALO Phase III study evaluating
the efficacy, safety and tolerability of two subcutaneous dose regimens
of fremanezumab for the preventive treatment of episodic migraine (EM),
were included in the Biologics License Application (BLA) for
fremanezumab that Teva submitted to the
For the full text of this publication, please visit: http://www.nejm.org/doi/full/10.1056/NEJMoa1709038
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 episodic migraine (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% 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 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.