Posted by Michael Wonder on 03 Feb 2019
Teva receives positive CHMP opinion for Ajovy (fremanezumab) for the prophylaxis of migraine in adults
1 February 2019 - If approved, Ajovy will be the first and only anti-CGRP treatment with quarterly and monthly dosing options in the European Union.
Teva Pharmaceutical Industries today announced that the CHMP of the EMA has recommended granting a marketing authorization for Ajovy (fremanezumab) 225 mg solution for injection in pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month.
The positive CHMP opinion is based on the review of a marketing authorisation application that included efficacy and safety data from the HALO clinical development program. The program evaluated fremanezumab in two pivotal Phase III clinical trials that enrolled patients with disabling migraine and studied fremanezumab as a prophylaxis of migraine in adults.
