CHMP positive opinion for Emgality for the prophylaxis of migraine .Eli Lilly
Eli Lilly and Company announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (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 FDA. Emgality is a humanized monoclonal antibody specifically designed to bind to the calcitonin gene-related peptide (CGRP), blocking its function without interacting with the CGRP receptor. Emgality is an investigational, once-monthly, self-administered injection under evaluation for the prevention of migraine, with no titration needed. This is the first regulatory step toward approval for Emgality in Europe. The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the European Union.
The CHMP positive opinion was based on Phase III 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. In EVOLVE-1 and EVOLVE-2, which studied patients with episodic migraine, the majority of patients (~60%) treated with Emgality achieved at least a 50 percent reduction, on average, in monthly migraine headache days in any given month (p<0.001) compared to 38.6 and 36 of patients on placebo in evolve-1 and evolve-2 respectively. in these studies more than one-third of patients achieved at least a 75 percent reduction on average in monthly migraine headache days in any given month p><0.001) compared to 19.3 and 17.8 of patient on placebo in evolve-1 and evolve-2 respectively. one in 7 patients 15.6 were migraine headache-free in any given month in evolve-1 on average p><0.001) compared to 6.2 of patients on placebo.>
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