Novartis has announced that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA) for AMG 334 (erenumab) for the prevention of migraine. Erenumab is an anti-CGRP monoclonal antibody developed to prevent migraine. It is the only one that is fully human and binds selectively to the CGRP receptor, believed to play a critical role in mediating the incapacitating pain of migraine.
"Novartis has a longstanding history of redefining clinical practice in neurology by bringing innovative medicines to those with the greatest need. We look forward to continuing this legacy by working with the European health authorities on our goal to make our fully human monoclonal antibody, erenumab, the first new therapy available to migraine patients in over a decade," said Vas Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis.
The regulatory submission to the EMA includes data from four Phase II and III clinical studies involving more than 2,600 patients experiencing four or more migraine days per month. These and other data will be presented at the 3rd Congress of the European Academy of Neurology (June 24-27, 2017, Amsterdam, the Netherlands). Across the comprehensive clinical program, erenumab demonstrated clinically meaningful, statistically significant and sustained efficacy versus placebo in reducing the number of migraine days per month. Erenumab also showed significant improvements on the impact migraine had on patients' disability and Quality of Life (emotional well-being and everyday life, such as missed work days or time spent away from friends and family), compared to placebo. In all studies, the safety profile of erenumab was comparable to placebo. In addition, an extension trial is ongoing, evaluating its long-term safety in people with migraine for up to five years.
Migraine is a chronic neurological disease characterized by recurrent attacks of moderate to severe head pain that is typically pulsating, often unilateral and associated with nausea, vomiting and sensitivity to light, sound and odors. Migraine has a profound and limiting impact on patients' abilities to carry out everyday tasks and as such, the World Health Organization has declared migraine to be one of the top ten causes of disability for men and women. It remains an area of significant unmet medical need. Existing preventive therapies have been repurposed from other indications and are often associated with poor tolerability and lack of efficacy, which lead to increasing discontinuation rates and dissatisfaction among patients.
Novartis and Amgen will co-commercialize AMG 334 (erenumab) in the US. Amgen has exclusive commercialization rights in Japan and Novartis has exclusive commercialization rights in rest of world. The companies will continue global co-development.