Successful results from three Phase III trials of galcanezumab for the treatment of migraine.- Eli Lilly

Eli Lilly and Company announced that galcanezumab, an investigational treatment for the prevention of episodic and chronic migraine, met its primary endpoint in three Phase III studies (EVOLVE-1, EVOLVE-2 and REGAIN) demonstrating statistically significant reductions in the number of monthly migraine headache days compared to placebo at both studied doses. In these three studies, the most commonly-reported adverse events were injection site reactions, including pain. The observed safety and tolerability profile was consistent with findings from previous studies of galcanezumab. Based on these results, Lilly will submit a Biologics License Application to the FDA for galcanezumab in the second half of 2017, followed by submissions to other regulatory agencies around the world.

EVOLVE-1 and EVOLVE-2 Study Results- In both studies, over the six-month treatment period, patients with episodic migraine treated with galcanezumab 120 mg and 240 mg doses experienced a significantly greater decrease in the average number of monthly migraine headache days compared to patients treated with placebo. EVOLVE-1: Average reduction of 4.7 days for 120 mg and 4.6 days for 240 mg compared to an average reduction of 2.8 days for placebo, p < 0.001 for both dosing groups. EVOLVE-2: Average reduction of 4.3 days for 120 mg and 4.2 days for 240 mg compared to an average reduction of 2.3 days for placebo, p < 0.001 for both dosing groups.Additionally, patients treated with galcanezumab experienced statistically significant improvement compared to placebo on several pre-specified secondary endpoints, including response rates and measures of daily activities.

REGAIN Study Results- Over the three-month treatment period, patients with chronic migraine treated with galcanezumab 120 mg and 240 mg doses experienced a significantly greater decrease in the average number of monthly migraine headache days compared to patients treated with placebo (average reduction of 4.8 days for 120 mg and 4.6 days for 240 mg compared to an average reduction of 2.7 days for placebo, p < 0.001 for both dosing groups). Additionally, patients treated with galcanezumab experienced statistically significant improvement compared to placebo on several pre-specified secondary endpoints, including response rates and measures of daily activities.

Comment: Lilly also is evaluating galcanezumab for the treatment of cluster headache, with Phase III trial results expected in 2018. Based on the unmet medical need and significance of this disease for patients, Lilly has been granted Fast Track Designation from the FDA.