Eli Lilly and Company received approval from the U.S. Food and Drug Administration (FDA) to market Emgality™ (galcanezumab-gnlm) for migraine prevention in adults on September 27, 2018. Emgality is the latest CGRP blocker for the prevention of migraine.1 Earlier this year, the FDA approved Aimovig™ (erenumab-aooe) and Ajovy™ (fremanezumab-vfrm).
What are CGRPs?
CGRP (calcitonin gene-related peptide) is a newly identified protein that has been discovered as a key component in some migraine attacks. CGRP is considered a neurotransmitter (a chemical messenger) and is present throughout the brain and body. Researchers have found that levels of CGRP are higher during a migraine attack, which led to the development of products to block the protein.
Emgality offered free to those with insurance
As part of their patient support program, Lilly is offering a year’s worth of Emgality treatment to those with commercial insurance, hoping to capture a significant portion of the migraine community despite being the third anti-CGRP to market. Offering the product free for a year will also allow time for the company to work with insurance companies on coverage, while providing those with migraine a new option for prevention.1
Lilly has stated that Emgality will be available in pharmacies soon. The list price of the drug is $575 monthly, or $6,900 annually.1
Emgality reduces migraine days
Emgality is a monoclonal antibody that targets CGRP, binding to the protein and inhibiting its activity. The CGRP blocker was studied in Phase III clinical trials in patients with episodic and chronic migraine. In the trial involving people with episodic migraine (4-14 migraine days a month), a third of patients saw their migraine days decrease by at least 75%, and two-thirds experienced a decrease of at least 50%. In people with chornic migraine (at least 15 migraine days a month), 28% had their migraine days cut in half, compared to 15% of those on placebo.1
Migraine prevention with a monthly injection
Emgality is a once-monthly injection that can be self-administered under the skin (subcutaneously). The recommended dose is an initial “loading” dose of 240 mg, given as two 120 mg injections, and a monthly maintenance dose of 120 mg.1,2
While the FDA approval is specifically for adults with migraine, Emgality has also been studied in cluster headache. Data from early clinical trials suggests that Emgality may also provide relief from cluster headache.3
Some patients in clinical trials experienced a hypersensitivity (allergic reaction) to Emgality, which can cause rash, itching, difficulty breathing, and swelling of the mouth, lips, tongue, or throat. The most common side effects experienced by patients taking Emgality in clinical trials were injection site reactions, such as soreness and redness.2
Lilly's Emgality™ (galcanezumab-gnlm) Receives U.S. FDA Approval for the Preventive Treatment of Migraine in Adults. PR Newswire. Available at https://www.prnewswire.com/news-releases/lillys-emgality-galcanezumab-gnlm-receives-us-fda-approval-for-the-preventive-treatment-of-migraine-in-adults-300720720.html. Accessed 9/28/18.
Emgality label. Available at http://pi.lilly.com/us/emgality-us-ppi.pdf. Accessed 9/28/18.
Highleyman L. Galcanezumab Offers Help for Cluster Headache and Migraine. Available at https://www.medpagetoday.com/meetingcoverage/ahs/73836. Accessed 9/28/18.