May 12, 2017 / 10:52 AM / 3 months ago

BRIEF-Lilly announces positive results for three phase 3 studies of galcanezumab

2 Min Read

May 12 (Reuters) - Eli Lilly And Co:

* Lilly announces positive results for three phase 3 studies of galcanezumab for the prevention of episodic and chronic migraine

* Eli Lilly and Co - galcanezumab, an investigational treatment for prevention of episodic and chronic migraine, met its primary endpoint

* Eli Lilly and Co - galcanezumab primary endpoint in three phase 3 studies (evolve-1, evolve-2 and regain)

* Eli Lilly and Co - also is evaluating galcanezumab for treatment of cluster headache, with phase 3 trial results expected in 2018

* Eli Lilly and Co - patients treated with galcanezumab experienced statistically significant improvement versus placebo on several pre-specified secondary endpoints

* Says it will submit a biologics license application to u.s. Food and drug administration (FDA) for galcanezumab in second half of 2017

* Eli Lilly and Co - based on unmet medical need and significance of this disease for patients, lilly has been granted fast track designation from FDA

* Says the BLA submission will be followed by submissions to other regulatory agencies around world

* Eli Lilly and Co- in the three studies, most commonly-reported adverse events were injection site reactions, including pain Source text for Eikon: Further company coverage:

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