First migraine prevention drug hits EU market

For the first time, migraine patients who experience four or more migraine days per month have access to a preventative treatment in the EU. Novartis’ mAb Aimovig (erenumab) was approved by the European Commission after receiving a recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) in early June. In two clinical trials, the once-monthly injection reduced overall migraine days per month considerably. Its efficacy as well as safety and tolerability exceeded that of existing prophylactic treatments.

“Migraine matters. It is a painful, highly disruptive neurological disease that affects all aspects of life, from going to work to spending time with family and friends,” commented Patrick Little, President of the European Migraine and Headache Alliance. “A treatment specifically designed for migraine prevention is a much-welcomed innovation and could transform lives of patients for whom current therapies do not work or are not well tolerated.”

Erenumab works by blocking a receptor called the calcitonin gene-related peptide receptor (CGRP-R), which plays a critical role in migraine attacks. It is the only CGRP-R pathway therapy specifically studied in patients who had failed on two to four previous treatments commonly used for migraine prevention. In the US, the drug has already received FDA approval for the preventive treatment of migraine in adults in May. 

“Erenumab heralds a new era in clinical practice, bringing both a targeted mechanism for prevention and a deep understanding of migraine, which we have never had before,” said Peter Goadsby, Director at NIHR-Wellcome Trust King’s Clinical Research Facility and Professor of Neurology at King’s College London. “We will see sustained relief from migraine for many of those who suffer with this debilitating disease.”

“Today’s approval is groundbreaking for people living with migraine, their families and doctors,”added Paul Hudson, CEO Novartis Pharmaceuticals. “In clinical trials, Aimovig has consistently shown to be effective in preventing migraine and bringing relief from the grip of this disease. We are proud to be the first to reimagine migraine prevention and we are committed to ensuring Aimovig’s availability for those who could benefit from it.”