Teva has received European Commission approval for its migraine drug, Ajovy (fremanezumab). The drug is a pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month.
The decision is based on two pivotal Phase III clinical trials, in which many patients on the treatment experienced significant reductions of at least 50% in the number of monthly migraine days with reduction observed as early as week one.
The drug, which is a monoclonal antibody, is the only anti-CGRP drug that has been approved for marketing, and was also approved by the US Food and Drug Administration (FDA) several months ago.
Messoud Ashina, Professor of Neurology in the Faculty of Health and Medical Sciences, University of Copenhagen, stated: “Migraine is a debilitating neurological disease which can have a substantial impact on quality of life. The disease is most common between the ages of 25 and 55 meaning that it strikes during the most productive years, disrupting patients’ personal and professional lives.
“The approval of fremanezumab in the EU will provide European physicians with an important new treatment option offering patients greater flexibility through monthly and quarterly dosing options and, most importantly, a significant reduction in the number of migraine days.”
Migraine is the most prevalent neurological disorder affecting more than 50 million people in Europe and one billion worldwide.
Revenue from Ajovy, which won FDA approval in September, was just $3 million in 2018 but is expected to grow to $150 million this year.