The Food and Drug Administration has approved galcanezumab-gnlm (Emgality) for the preventive treatment of migraine in adults, according to an announcement from Eli Lilly, the drug’s manufacturer.
FDA approval is based on results of three different phase 3 clinical trials, EVOLVE-1, EVOLVE-2, and REGAIN. EVOLVE-1 and EVOLVE-2 were 6-month, double-blind, placebo-controlled studies that included adults with episodic migraine (4-14 headache days per month). REGAIN was a 3-month, double-blind, placebo-controlled study of adults with chronic migraine (at least 15 headache days per month). The primary endpoint of all trials was mean change from baseline in the number of monthly headache days.
In all trials, patients received either placebo, 120 mg galcanezumab-gnlm after an initial loading dose of 240 mg, or 240 mg galcanezumab-gnlm. In EVOLVE-1 and EVOLVE-2, people who received galcanezumab-gnlm had significantly fewer headache days per month than with 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 headache days than those who received placebo, and were also more likely to achieve a 50% reduction in headache days. There was no difference between groups in 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 was injection site reaction.
Galcanezumab-gnlm, a calcitonin gene–related peptide antagonist, is also under final review by the European Commission for approval in Europe.
The U.S. list price of galcanezumab-gnlm is $575 once-monthly, or $6,900 annually, and patients with commercial insurance are candidates to receive it free for up to 12 months as part of Lilly’s patient support program (subject to specific terms and conditions), according to the announcement.