The European Commission (EC) has granted the Marketing Authorisation 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.
AJOVY, a humanised monoclonal antibody (mAb) that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor, was evaluated in two pivotal Phase III clinical trials that enrolled patients with disabling migraine and studied fremanezumab as a prophylactic treatment for migraine in adults.
In these trials, patients treated with fremanezumab had a significantly greater reduction in migraine days compared to placebo. Adverse drug reactions (ADRs) observed with fremanezumab were mostly mild to moderate, short-lasting skin reactions around the injection area including pain, hardening, redness, itching and rash at the injection site.
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 years.
It is the first and only anti-CGRP drug approved in the European Union (EU) and the United States (US) that is designed for the prevention of migraine that offers both quarterly and monthly dosing options for the phrophylatic treatment of migraine.
The EC decision is applicable to all 28 EU member states plus Iceland, Norway and Liechtenstein after transposition into legally binding acts in these countries. AJOVY received U.S. FDA approval for the preventive treatment of migraine in adults on 14 September 2018. Additional regulatory filings are underway with other health authorities worldwide.
Elena Ruiz de la Torre, Executive Director, European Migraine & Headache Alliance (EMHA) said: “Migraine is not just a headache, it is an unpredictable neurological disease which can frequently go undiagnosed and undertreated.
“After decades of migraine patients feeling left behind, we are delighted to see the progression of preventive treatments which offer patients new hope in managing their condition. We welcome the fact that Europe’s more than 50 million patients will now have greater choice over their treatment options and more days uninterrupted by migraine.”
Richard Daniell, Executive Vice President, European Commercial at Teva said: “It is our hope that AJOVY® will provide patients and European healthcare professionals with a preventive treatment which offers patients more migraine free days as well as greater flexibility in managing this unpredictable disease.”