Eli Lilly and Company has secured approval from the US Food and Drug Administration (FDA) for its migraine drug Emgality (galcanezumab-gnlm) as a preventative therapy for adults. The approval marks a significant milestone for Lilly, as Emgality becomes available as a once-monthly, self-administered, subcutaneous injection designed to help prevent migraines.

Emgality, a calcitonin gene-related peptide (CGRP) antagonist, is set to be priced at $575 per monthly injection or $6,900 annually. However, the drug is contraindicated for individuals who are severely allergic to galcanezumab-gnlm or any of its components.

Following the FDA approval, Eli Lilly will roll out Emgality to retail pharmacies, with the medication expected to be available for pickup soon. Additionally, Lilly is offering Emgality at no cost to patients with commercial insurance for up to one year through its patient support program.

The FDA’s decision was influenced by the results of three Phase 3 clinical trials: EVOLVE-1 and EVOLVE-2, which focused on patients with episodic migraines, and REGAIN, which examined individuals with chronic migraines. These trials demonstrated the efficacy and safety of Emgality in preventing migraine attacks.

The recommended treatment regimen for Emgality involves an initial loading dose of 240 mg, administered as two consecutive 120 mg subcutaneous injections. This is followed by a maintenance dose of 120 mg once a month.

Christi Shaw, President of Lilly Bio-Medicines, expressed enthusiasm about the approval, noting that despite the profound impact of migraines, only about 10 percent of sufferers currently use preventative treatments. She highlighted Lilly’s commitment over two decades to address this unmet need.

Jill Dehlin, Chair of the Patient Leadership Council at the National Headache Foundation, shared her personal experience with migraines and voiced appreciation for the development of new treatment options, acknowledging the efforts of researchers and clinical trial participants.

In related news, Emgality recently received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the preventive treatment of migraines. This opinion is anticipated to influence the European Commission’s approval process.

  Christi Shaw, Eli Lilly, Eli Lilly and Company, Emgality, galcanezumab, galcanezumab-gnlm, Jill Dehlin, Migraine, migraine prevention, National Headache Foundation, Phase 3 clinical trials, US FDA, US Food and Drug Administration, USA