Teva Pharmaceutical announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for fremanezumab, an anti-calcitonin gene-related peptide (CGRP) antibody for the prevention of episodic and chronic migraine in adults. Fremanezumab is a quarterly or monthly injection that may be administered by a healthcare professional, or self-administered by the patient.
“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 U.S. Food and Drug Administration,” said Ernesto Aycardi, MD, Vice President Head of Clinical Trial Execution, Data Sciences and Biometrics & Clinical Pharmacology at Teva. “With limited availability of preventive therapy options that target the underlying biological mechanisms of migraine, the MAA acceptance represents a major step toward advancing the treatment paradigm for the migraine community. These two significant regulatory milestones in the migraine indication, combined with our clinical development programs for fremanezumab in cluster headache and post-traumatic headache, highlight Teva’s commitment to patients worldwide with these debilitating conditions.”
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.
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 FDA. Trial participant recruitment is now underway and the studies are expected to conclude in early 2019. Fast track designation is intended to facilitate development and expedite review of drugs to treat serious or life-threatening conditions. Additionally, Teva has also recently initiated a fremanezumab Phase II clinical program for the treatment of post-traumatic headache disorder.
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 Japan, nearly 75 million people suffer from episodic and chronic migraine. In the EU5, more than 15 million people suffer from episodic and chronic migraine. According to the most recent Cost of Brain Disorders in Europe paper, migraine costs the economy €18 billion annually in reduced productivity and work days lost. 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.