AMG 334 (erenumab) filed in EU for the prevention of migraine- Novartis

Novartis announced that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA) for AMG 334 (erenumab) for the prevention 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. 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. These and other data will be presented at the 3rd Congress of the European Academy of Neurology.