Lilly to submit galcanezumab BLA after trial success

15 May 2017

Galcanezumab, an investigational treatment for the prevention of episodic and chronic migraine from US pharma major Eli Lilly (NYSE: LLY), met its primary endpoint in three Phase III studies, the company has announced.

Data from the EVOLVE-1, EVOLVE-2 and REGAIN trials showed that the monoclonal antibody caused statistically-significant reductions in the number of monthly migraine headache days compared to placebo at both studied doses.

In the 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.

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