INDIANAPOLIS, Sept. 21, 2018
Lilly Receives Positive CHMP Opinion for EmgalityTM (galcanezumab) for the Prophylaxis of Migraine in Adults
Eli Lilly and Company announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Emgality TM (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. Food and Drug Administration (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.
Migraine is a neurological disease characterized by recurrent episodes of a severe headache accompanied by other symptoms including nausea, vomiting, sensitivity to light and sound, and changes in vision.
"Migraine affects more than 100 million people globally, making it the third most prevalent disease in the world. Migraine can also have a significant impact on a person's ability to fully participate in their personal and professional life," said Gudarz Davar, M.D., vice president, Neurology Development, Lilly Bio-Medicines. "If approved, we're very excited about the potential to offer Emgality as a new option for migraine prevention that could provide more migraine-free days to people living with this debilitating disease."
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.
Emgality has been studied in more than 2,500 patients in clinical studies for migraine prevention. More than 1,400 patients were exposed to Emgality during the placebo-controlled Phase 3 studies, with less than 2.5% of patients discontinuing due to treatment-related adverse events.
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