Teva's migraine prophylaxis drug now approved in Europe

Following a positive European Medicines Agency advisory recommendation in February, the European Commission has granted the Marketing Authorization for Ajovy (fremanezumab) 225mg solution for injection in pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month.

Although Teva Pharmaceutical Industries’ (NYSE: TEVA) Ajovy was not the first of its class to be approved, according to Teva it is the first and only anti-CGRP drug approved in the European Union and the USA that is designed for the prevention of migraine that offers both quarterly and monthly dosing options for the phrophylactic 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 US Food and Drug Administration approval for the preventive treatment of migraine in adults on September 14, 2018. Additional regulatory filings are underway with other health authorities worldwide.