EU regulators review Novartis’ migraine drug

An experimental therapy being developed by Amgen and Novartis to prevent migraine has been accepted for review in the European Union.

Erenumab (AMG 334) is a fully human monoclonal antibody specifically designed to target and block the Calcitonin Gene-Related Peptide (CGRP) receptor, which is thought to play a critical role in mediating the incapacitating pain of migraine.

The submission includes data from four Phase II and III clinical studies involving more than 2,600 patients experiencing four or more migraine days per month, data from which are to be presented at the upcoming Congress of the European Academy of Neurology in Amsterdam later this month.

The World Health Organisation considers migraine to be one of the top ten causes of disability for men and women, and yet, it remains an area of significant unmet medical need.

According to Novartis, erenumab has consistently demonstrated "clinically meaningful, statistically significant and sustained efficacy" in cutting down the number of migraine days experienced per month versus placebo, as well as "significant improvements" in related disability and Quality of Life, with a safety profile comparable to placebo.

The submission, it says, "is a first step towards addressing a significant unmet need for people with migraine, who have had very few new treatment options since the 1990’s".

Novartis and Amgen are to co-commercialise erenumab in the US, while Amgen has exclusive commercialisation rights in Japan and Novartis in rest of world.