Marks the first Phase III chronic migraine data to be published within anti-CGRP class
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the publication of data from the pivotal Phase III HALO study evaluating the efficacy, safety and tolerability of two subcutaneous dose regimens of fremanezumab for the preventive treatment of chronic migraine (CM). These data were published online today by the New England Journal of Medicine (NEJM) and will appear in a subsequent print issue.
“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 Thomas Jefferson University Hospital and lead author of this publication. “Results from the Phase III study of fremanezumab for the preventive treatment of chronic migraine highlight the importance of therapies targeting CGRP as a potential significant advancement in the treatment of patients suffering from debilitating symptoms.”
“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 Ernesto Aycardi, M.D., Vice President & Therapeutic Area Head, R&D, Migraine and Headache at Teva. “In this article, we are pleased to share with the medical community data from what we believe is a differentiated, patient-centric clinical development program, and to advance understanding of the potential of fremanezumab as a preventive treatment option for the millions of people suffering from migraine.”
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 U.S. Food and Drug Administration (FDA) in October. The most common adverse events reported in clinical trials include injection site induration, erythema, and pruritis.
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 Japan, nearly 75 million people suffer from episodic and chronic migraine – more than 38 million in the U.S. alone. Of the approximately 40% of patients suffering from migraine for whom prevention is appropriate, only 13% are currently receiving therapy. There remains a significant medical need for treatments designed specifically to prevent migraine. According to recent analysis, the economic burden for migraine patients reaches approximately $78 billion per year in the U.S.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by approximately 200 million patients in 100 markets every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has the world-leading innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products. Teva is leveraging its generics and specialty capabilities in order to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva's net revenues in 2016 were $21.9 billion. For more information, visit www.tevapharm.com.
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:
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