Migraine prevention treatment from Novartis receives European approval
Migraine prevention treatment from Novartis receives European approval 1 August 2018 The European Commission (EC) has approved Novartis’ Aimovig (erenumab) for the prevention of migraine in adults experiencing four or more migraines per month. × Expand migraine
Aimovig works by blocking a receptor called the calcitonin gene-related peptide receptor (CGRP-R), which plays a critical role in mediating the pain related to migraines. Its safety and efficacy have been demonstrated in several large, global, randomized, double-blind, placebo-controlled studies, in which patients receiving Aimovig experienced consistent and sustained migraine prevention with many experiencing a reduction by half of the number of monthly migraine days.
“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,” said 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 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,” added Dr Peter Goadsby, PhD, FRCP, director, 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,” explained 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. We are launching a tailored post-approval access program and are exploring a number of innovative reimbursement and access approaches, including paying only for patients who respond well to treatment.”
With this approval, Aimovig becomes the only treatment specifically designed to prevent migraines approved in the European Union, Switzerland, the US and Australia.
Novartis and Amgen are co-commercialising Aimovig in the US. Amgen has exclusive commercialisation rights to the drug in Japan and Novartis has exclusive rights to commercialise in the rest of the world. Tags