21 June 2017 - Filing is supported by a comprehensive clinical program of over 2,600 migraine patients demonstrating sustained efficacy and placebo-like safety profile of AMG 334 (erenumab).

Novartis today announced that the EMA has accepted its Marketing Authorisation Application 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.

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.

Read Novartis press release