FDA Approves Galcanezumab for Migraine Prevention

ROCKVILLE, MD—The FDA has approved galcanezumab-gnlm (Emgality) for the preventive treatment of migraine in adults. Eli Lilly and Company manufactures the therapy. Emgality is the third calcitonin gene-related peptide (CGRP) antagonist to receive regulatory approval.

The approval is based on the results of three phase III clinical trials: EVOLVE-1, EVOLVE-2, and REGAIN. EVOLVE-1 and EVOLVE-2 were six-month, double-blind, placebo-controlled studies that included adults with episodic migraine. REGAIN was a three-month, double-blind, placebo-controlled study of adults with chronic migraine. The primary end point of all three trials was mean change from baseline in the number of monthly headache days.

In all trials, patients received either placebo, 120 mg of galcanezumab-gnlm after an initial loading dose of 240 mg, or 240 mg of galcanezumab-gnlm. In EVOLVE-1 and EVOLVE-2, people who received galcanezumab-gnlm had significantly fewer headache days per month than people who received placebo, and those who received galcanezumab-gnlm were also more likely to achieve a 50%, 75%, and 100% reduction in headache days.

In REGAIN, patients who received galcanezumab-gnlm experienced fewer monthly headache days than those who received placebo and were more likely to achieve a 50% reduction in headache days. There was no difference between groups in the likelihood of achieving a 75% or 100% reduction.

The recommended dosage, according to the label, is a monthly, 120-mg subcutaneous injection with an initial loading dose of 240 mg. The most common adverse event associated with galcanezumab-gnlm is injection-site reaction.

Galcanezumab-gnlm is under final review by the European Commission for approval in Europe.

—Lucas Franki