Teva Pharmaceutical Industries’ AJOVY® (fremanezumab) would be the first calcitonin gene–related peptide inhibitor with quarterly and monthly dosing options.
Approximately 1 billion people worldwide suffer from migraines, according to the Migraine Research Foundation, more than 50 million of whom reside in Europe. Those patients may soon have access to another treatment option.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently recommended granting a marketing authorization for AJOVY® (fremanezumab) 225 mg, a solution for injection delivered through a pre-filled syringe, for the prophylaxis of migraine in adults who have at least four migraine days per month. Fremanezumab is a humanized monoclonal antibody that binds to the calcitonin gene–related peptide (CGRP) ligand, blocking its ability to bind to the receptor. AJOVY was specifically developed for the treatment of migraines and, unlike other anti-CGRP medicines available in Europe, has both both quarterly and monthly dosing options.
The positive recommendation by the CHMP was based on results obtained in the HALO clinical trials conducted by Teva. These trials included two pivotal phase III studies that enrolled patients with disabling migraine. Patients treated with AJOVY experienced greater reductions in migraine days than those receiving a placebo.
The recommendation will be reviewed by the European Commission, which will determine whether the drug receives approval for use in the 28 countries of the EU. The decision is expected in the second half of 2019.