Eli Lilly and Co. said Emgality met its main goal of reducing monthly headaches by 4.1 days among certain migraine patients in a late-stage study.
The phase 3 trial, dubbed Conquer, evaluated the safety and efficacy of Emgality as a preventive treatment of chronic and episodic migraine in 462 patients — 193 with chronic migraine, and 269 with episodic migraine — who also had documented treatment failures after using two to four preventive therapies.
Chronic migraine is characterized by 15 or more headache days each month, while with episodic migraine, patients have 14 or fewer headache days per month.
The trial showed patients who received Emgality within a three-month treatment period experienced a reduction in their monthly migraine headaches by 4.1 days, compared to 1 day for the placebo group. Patients in the study had an average 13.2 headache days per month.
Additionally, patients receiving Emgality experienced improvements in their daily social and work-related activities that were previously limited by migraine.
Indianapolis-based Lilly said Emgality's safety profile was consistent with other late-stage studies which investigated the drug in migraine and cluster headache.
The U.S. Food and Drug Administration approved Emgality, or galcanezumab, for the preventive treatment of migraine in adults in September 2018. Meanwhile, the drug received FDA approval in June as the first medicine for episodic cluster headaches in adults.