New Migraine Prophylaxis Drug Approved by FDA

The FDA has approved Emgality (galcanezumab-gnlm), 120-mg injection, for the prophylactic treatment of migraine in adults, making it the third such biologic agent to be approved in 2018. The agency approved Aimovig (erenumab-aooe) on May 17 and Ajovy (fremanezumab-vfrm) on September 14.

Like Aimovig and Ajovy, Emgality acts by reducing the effect of calcitonin gene-related peptide (CGRP), which is believed to have a physiologic role in migraine. Emgality is a once-monthly, self-administered, subcutaneous injection. The recommended dose of the humanized monoclonal antibody is 240 mg (2 consecutive subcutaneous injections of 120 mg each) once as a loading dose, followed by monthly doses of 120 mg injected subcutaneously.

The efficacy and safety of Emgality were demonstrated in 2 phase-3 clinical trials in patients with episodic migraine (EVOLVE-1 and EVOLVE-2) and 1 phase-3 clinical trial in patients with chronic migraine (REGAIN). The 3 trials enrolled more than 2,500 patients.

Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients. Hypersensitivity reactions (eg, rash, urticaria, dyspnea) have been reported with Emgality in clinical trials. The most common adverse effects associated with Emgality use were injection-site reactions, sinusitis, and urinary tract infection.

Reference:
Lilly's Emgality™ (galcanezumab-gnlm) Receives U.S. FDA Approval for the preventive treatment of migraine in adults [press release]. Indianapolis, IN: Eli Lilly and Co; September 27, 2018. https://investor.lilly.com/news-releases/news-release-details/lillys-emgalitytm-galcanezumab-gnlm-receives-us-fda-approval. Accessed October 1, 2018.