Eli Lilly and Company (NYSE: LLY) today announced the upcoming presentation of results from pooled subgroup analyses of efficacy data from the Phase 3 EVOLVE-1 and EVOLVE-2 studies. These analyses demonstrate a reduction in monthly migraine headache days with Emgality® (galcanezumab-gnlm) versus placebo in patients with low- and high-frequency episodic migraine.1 Detailed results will be presented in an oral platform presentation (S17.003) at the Annual Meeting of the American Academy of Neurology (AAN) taking place in Philadelphia from May 4-10, 2019.
“Migraine causes people to suffer from substantial pain and impairment, no matter how frequently they occur. These collective analyses of more than 1,700 patients with episodic migraine from our Phase 3 Emgality program reflect our continued commitment to aid people living with this serious neurologic disorder,” said Gudarz Davar, M.D., vice president, Neurology Development, Lilly Bio-Medicines.
In these analyses of the EVOLVE-1 and EVOLVE-2 trials, patients were stratified by low-frequency (from four to less than eight monthly migraine headache days) and high-frequency (from eight to 14 monthly migraine headache days) subgroups. Emgality 120 mg and 240 mg demonstrated a statistically significant reduction in monthly migraine headache days in both the low- and high-frequency subgroups, when compared with placebo.1 Analyses of a number of secondary endpoints demonstrated statistically significant improvements in both low- and high-frequency subgroups compared to placebo, including the mean percentage of patients with ≥50%, ≥75% and ≥100% reduction from baseline in overall monthly migraine headache days and the impact of Emgality on quality of life measurements.1