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Lilly’s migraine drug galcanezumab succeeds in three phase 3 studies

Published 15 May 2017

Eli Lilly's galcanezumab has met its primary endpoint in three phase 3 studies (EVOLVE-1, EVOLVE-2 and REGAIN) showing statistically significant reductions in the number of monthly migraine headache days against placebo at both studied doses.

"The robust results from these three studies bring us one step closer to helping people experience more migraine-free days, an important treatment goal for those living with this serious disease," said Christi Shaw, president of Lilly Bio-Medicines.

"The impact of migraine is underestimated, with people who experience migraine attacks often missing work, family activities or social engagements. For patients with as few as one migraine headache day per week, this can mean more than 50 days of lost productivity a year."

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 U.S. Food and Drug Administration (FDA) for galcanezumab in the second half of 2017, followed by submissions to other regulatory agencies around the world.

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.

"Lilly's commitment to the development of new treatments for migraine has spanned more than 25 years, and in that time, we have played an important role in advancing the understanding of this serious disease," said Robert Conley, M.D., Distinguished Lilly Scholar and Lilly global development leader for migraine therapeutics. "The topline results from these Phase 3 data are encouraging and reaffirm the potential for galcanezumab to provide a new option for people living with migraine."

Lilly will present detailed data from these studies at scientific meetings later this year and submit the results to peer-reviewed journals.

Lilly also is evaluating galcanezumab for the treatment of cluster headache, with Phase 3 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.



Source: Company Press Release