CHMP recommends approval of Ajovy in migraine.- Teva Pharma

Teva Pharmaceutical announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency 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. If approved by the European Commission, Ajovy, a humanized monoclonal antibody that binds to the calcitonin gene-related peptide ligand and blocks its binding to the receptor, will be the first and only anti-CGRP treatment in the European Union with both quarterly and monthly dosing options.

The positive CHMP opinion is based on the review of a Marketing Authorization 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. In these trials, patients treated with fremanezumab had a significantly greater reduction in migraine days compared to placebo. Adverse drug reactions observed with Ajovy were mostly mild to moderate, short-lasting skin reactions around the injection area: pain, hardening, redness, itching and rash at the injection site.