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

Galcanezumab, a one-monthly self-administered injection, is a monoclonal antibody designed to bind 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 2,901 patients took part in these trials. 

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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 (P<0.001). In EVOLVE-2, this reduction was 59.3% and 56.5% for the 120mg and 240mg doses, respectively, vs. 36.0% for placebo (P<0.001). In REGAIN, reductions were 27.6% and 27.5% for patients receiving galcanezumab 120mg and 240mg, respectively, vs. 15.4% for placebo.

“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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