Phase III post-hoc analysis of Emgality shows reduction in migraine frequency.- Eli Lilly.

Eli Lilly announced results from a post-hoc analysis of three Phase III studies (EVOLVE-1, EVOLVE-2 and REGAIN) which demonstrated efficacy of Emgality (galcanezumab-gnlm) in patients with episodic and chronic migraine who had previously failed preventive treatment with Botox (onabotulinumtoxinA). In this subgroup analysis, patients treated with both doses of Emgality who previously failed preventive treatment with Botox experienced a statistically significantly greater reduction in the average number of monthly migraine headache days, and a statistically significantly greater percent (at least a 50 percent) reduction in the number of migraine headache days, compared to patients treated with placebo.

The average reduction in monthly migraine headache days is 3.91 days for 120 mg and 5.27 days for 240 mg compared to 0.88 days for placebo. The mean percentages of patients with at least 50 percent reduction in monthly migraine headache days: 41.3% for 120 mg and 47.5% for 240 mg compared to 9.4% for placebo. As previously reported in these Phase III studies, the most commonly-reported adverse events were injection site reactions.

The post-hoc analysis reviewed the mean change from baseline in the number of monthly migraine headache days and the proportion of patients with at least a 50 percent reduction in number of monthly migraine headache days in patients who had previously failed Botox due to lack of efficacy or tolerability issues, using integrated EVOLVE-1 and EVOLVE-2 trial results and REGAIN results.

In this integrated analysis of patients who had previously failed treatment with Botox, patients treated with Emgality also had statistically significant improvements in quality of life, as measured by the Migraine-Specific Quality of Life Questionnaire (MSQ) and the Patient Global Impression of Severity (PGI-S) rating. Detailed results will be presented at the American Headache Society (AHS) annual meeting.

Comment: Emgality is a monoclonal antibody specifically designed to bind to and reduce the overactivity of calcitonin gene-related peptide (CGRP), providing an investigational once-monthly, self-administered injection under evaluation for the prevention of migraine and cluster headache.