Eli Lilly’s Emgality
Eli Lilly (LLY) announced in its press release on June 27 the results from the post-hoc analysis involving three studies evaluating Emgality (galcanezumab-gnlm) for the treatment of episodic and chronic migraines in patients who did not respond to preventive treatment with Botox (onabotulinumtoxinA).
The above chart shows key highlights for Emgality in a migraine. The post-hoc analysis of three phase three studies include the EVOLVE-1, EVOLVE-2, and REGAIN studies.
US FDA and Emgality
Emgality (galcanezumab-gnlm) is presently under review by the US Food and Drug Administration (or FDA) for migraine prevention.
The studies included in the post-hoc analysis were phase three, double-blind, randomized, placebo-controlled studies evaluating the efficacy of Emgality 120 mg and 240 mg for the treatment of patients with episodic or chronic migraines.
The analysis included the evaluation of patients treated with Emgality in the EVOLVE-1 and EVOLVE-2 studies for six months and patients treated with Emgality in the REGAIN study for three months.
The results showed a reduction in monthly migraine headache days by ~3.9 days for Emgality 120 mg dosage, ~5.3 days for Emgality 240 mg dosage, and ~0.9 days for the placebo. Also, the mean percentage for patients with at least a 50% reduction in monthly migraine headaches was 41.3% for Emgality 120 mg dosage, 47.5% for Emgality 240 mg dosage, and 9.4% for the placebo.
Eli Lilly will present detailed results for the study at the American Headache Society’s annual meeting on Saturday, June 30, 2018, as a late-breaking presentation.