The Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for the investigational migraine prevention treatment, galcanezumab (Eli Lilly).

Galcanezumab, a once-monthly self-administered injection, is a monoclonal antibody designed to bind to and inhibit the activity of calcitonin gene-related peptide (CGRP). The treatment would be delivered via an auto-injector pen or prefilled syringe. The application includes data from three Phase 3 trials; EVOLVE-1, EVOLVE-2 (6 months) and REGAIN (3 months). A total of 2901 patients took part in these trials.

In EVOLVE-1, 62.3% and 60.9% of patients receiving galcanezumab 120mg and 240mg, respectively, had at least a 50% reduction in migraine days vs. 38.6% for placebo (<.001).

In EVOLVE-2, this reduction was 59.3% and 56.5% for the 120mg and 240mg doses, respectively, vs. 36.0% for placebo (<.001). In REGAIN, reductions were 27.6% and 27.5% for patients receiving galcanezumab 120mg and 240mg, respectively, vs. 15.4% for placebo.


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“We are truly pleased to be one step closer to potentially providing a new self-administered and effective preventive treatment option that may help people experience fewer migraine days,” said Christi Shaw, president of Lilly Bio-Medicines. 

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Reference

FDA accepts Biologics License Application (BLA) to review galcanezumab for the prevention of migraine in adults [press release]. Indianapolis; Eli Lilly and Company: December 11, 2017. Accessed December 14, 2017.

This article originally appeared on MPR