Teva (NYSE:TEVA) said yesterday that it won EC Marketing Authorization in the European Union for its Ajovy pre-filled syringe injection meant to serve as a prophylaxis for migraines in adults who experience at least four migraine days per month.
The Israel-based company said that Ajovy is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide ligand and blocks its binding to the receptor.
Teva touted that Ajovy is the first and only anti-CGRP drug approved in the European Union and the U.S. intended for the prevention of migraine that offers both quarterly and monthly dosing options.
“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,” Messoud Ashina of the University of Copenhagen said in a prepared statement.
Data supporting the clearance came from two pivotal Phase III clinical trials that indicated that patients treated with Ajovy had significantly greater reduction in migraine days compared to placebo. Adverse drug reactions were mostly mild to moderate, short-lasting skin reactions around the injection area, including pain, hardening, redness, itching and rash at the injection site.
Teva said that Ajovy won FDA approval last September and that it has also filed for regulatory clearance with other global regulatory bodies.
“Migraine can have a significant impact on the day-to-day life of patients with some experiencing 15 headache days per month. 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. The approval of fremanezumab is also an important step in our focus on biopharmaceuticals, the next generation of innovative medicines, coupled with our ongoing commitment to developing treatments for disorders of the central nervous system,” Teva European commercial exec VP Richard Daniell said in a press release.