Lilly Announces Positive Results for Three Phase 3 Studies of Galcanezumab for the Prevention of Episodic and Chronic Migraine

May 12, 2017 - (Newswire)

- Eli Lilly and Company (NYSE: LLY) announced today that galcanezumab, an investigational treatment for the prevention of episodic and chronic migraine, met its primary endpoint in three Phase 3 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.

"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.

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

Original Source: https://www.newswire.com/news/lilly-announces-positive-results-for-three-phase-3-studies-of-galcanezumab-for

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