21 September 2018 - Eli Lilly announced today that the EMA's CHMP has issued a positive opinion for Emgality (galcanezumab) for the prophylaxis of migraine in adults who have at least four migraine days per month.

In June 2018, Lilly announced the intended brand name, Emgality, was conditionally accepted by the U.S. FDA.

The CHMP positive opinion was based on Phase 3 data from two clinical trials in patients with episodic migraine (EVOLVE-1 and EVOLVE-2) and one Phase 3 clinical trial in patients with chronic migraine (REGAIN). In all three clinical trials (EVOLVE-1, EVOLVE-2 and REGAIN), Emgality reduced mean monthly migraine headache days in the first month and every following month in the treatment period compared to placebo.

Read Eli Lilly press release