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Lilly's Emgality Joins the CGRP Club

September 28, 2018
FDA approves third migraine prevention medication in the new class.

A PPM Brief

Galcanezumab-gnlm, branded Emgality, is the third calcitonin gene-related peptide targeting migraine prevention medication to earn FDA’s approval. Developed by Eli Lilly and Company (Indianapolis), Emgality is self-administered (120 mg) once-monthly via subcutaneous injection. The CGRP antagonist is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients used in the drug’s manufacturing process. The recommended dose for Emgality is 240 mg (two consecutive subcutaneous injections of 120 mg each), once as a loading dose, followed by monthly doses of 120 mg; the monoclonal antibody will be marketed at $575, or $6,900 annually, according to a company news release.

“The efficacy and safety of Emgality [were] demonstrated in two Phase 3 clinical trials in patients with episodic migraine (EVOLVE-1 and EVOLVE-2) and one Phase 3 clinical trial in patients with chronic migraine (REGAIN),” noted the release. For details on the studies, featured an exclusive CGRP manufacturer roundtable, see the PPM backstory. 

New class of medications target the CGRP receptor, pictured.New class of medications target the CGRP receptor, pictured.(Credit: 123RF)

Overall, the EVOLVE-1 study showed that subjects reduced their mean number of migraine headache days per month by -4.7 (n=210) compared to -2.8 placebo (n=425). The EVOLVE-2 study demonstrated a reduction of -4.3 (n=226)  migraine headache days using Emgality versus -2.3 (n=450) on placebo, with both studies showing that nearly 60% of subjects had at least a 50% reduction in migraine headache days in any given month on average. The REGAIN study revealed a mean reduction from baseline of -4.8 (n=273) migraine headache days per month compared to -2.7 (n=538) for those on placebo. In this study, the 120 mg dose “was not significantly better than placebo for the proportion of patients with 75% and 100% reduction from baseline in the number of monthly MHDs over the three-month treatment period,” according to the news release.

Safety clinical trials included more than 2,500 patients, with hypersensitivity reactions (eg, rash, urticaria and dyspnea) reported, including with reactions showing up days after administration. The most common adverse reactions were injection site reactions.

The first two medications approved in the new CGRP antagonist prophylactic migraine class were: Aimovig (Amgen/Novartis, May 2018)  and AJOVY (Teva, mid-September 2018). 

Last updated on: September 28, 2018
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