FDA Approves Galcanezumab for Prevention of Migraine


The Food and Drug Administration (FDA) has approved galcanezumab-glnm (Emgality; Lilly, Indianapolis, IN) for the prevention of migraine in adults. Galcanezumab is available as a self-administered subcutaneous injection (120 mg) and will be available in retail pharmacies with a prescription. The recommended dose is 240 mg (two consecutive subcutaneous injections of 120 mg each) once as a loading dose, followed by monthly doses of 120 mg.

The price is $575 per injection. Some patients with commercial insurance will be able to receive up to 12 months of galcanezumab at no cost as part of Lilly's patient support. Galcanezumab is a calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of migraine in adults and is the third CGRP-related treatment for patients with migraine to be approved this year. 

Approval was based upon efficacy and safety shown the EVOLVE-1 (NCT02614183), EVOLVE-2 (NCT02614196)and REGAIN (NCT02614261) phase 3 clinical trials, all of which were double-blind placebo-controlled studies using an initial loading dose of 240 mg galcanezumab followed by a monthly dose of 120 mg. 

The EVOLVE trials were both 6-month trials in patients with episodic migraine (14 migraine headache days [MHD]/month), and patients treated had a mean change of -4.7 and -4.3 MHD/month respectively compared to -2.8 and -2.3 in those treated with placebo (P < .001). In both of these trials, approximately 3 out of 5 patients had at least a 50% reduction in the number of headaches experienced each month. 

In the REGAIN trial, a 3-month study of patients with chronic migraine (15 or more MHD/month), treated patients had a mean change of -4.8 MHD/month compared to -2.7 for those given placebo (P < .001). At least a 50% reduction in MHD in a given month occurred in 28% of patients treated compared 15% of those given placebo (P < .001), although for those who had 75% or 100% reduction from baseline MHD over the full 3 months was not significantly different from placebo. 

"Despite the devastating impact of migraine, only about 10 percent of people living with the disease are currently taking a preventive treatment," said Christi Shaw, president, Lilly Bio-Medicines. "For more than two decades, Lilly has recognized this unmet need, and we have worked tirelessly to develop a new option specifically designed for the prevention of migraine. With this approval, we are thrilled to offer a preventive treatment option to adults living with this disease."


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