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
preventive therapeutic options
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine.
“The BLA submission for fremanezumab marks a very important milestone for the migraine community,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “There have been few therapeutic innovations for migraine patients in over 25 years. If approved, fremanezumab will be among the first to enter the market in a new class of drugs for the preventive treatment of migraine. We are immensely proud of the progress we have made in the fremanezumab development program, and look forward to the potential to make this therapy available to the millions of people around the world who live with the debilitating effects of migraine.”
“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 Ernesto Aycardi, M.D., Vice President, Therapeutic Area Head, Migraine & Headache at Teva. “We are very excited to have submitted the BLA to the FDA as an important step in being able to introduce a new therapy that may help to address a significant need in the migraine community for targeted, preventive treatment options.”
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 Congress of the International Headache Society (IHC) in September and will be published in future peer-reviewed publications. The most common adverse events reported in clinical trials include injection site induration, erythema, and pruritis.
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 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 over 60 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 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.
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