New Indication for Emgality to Treat Cluster Headaches
June 5, 2019 – The U.S. FDA has approved a new indication for Emgality® (galcanezumab-gnlm) solution for injection, manufactured by Eli Lilly. The product, which first received approval in 2018 to prevent migraines, is now indicated to treat episodic cluster headaches in adults. It is the first drug to receive FDA approval for this indication that reduces the frequency of attacks.
Cluster headaches are a severe pain syndrome that affects an estimated 1–2 people out of every 1,000. Lasting for up to three hours, the headaches occur in groups and can strike multiple times in one day. Each cluster cycle usually lasts for weeks or months, interspersed with periods of remission. The pain, which begins behind or around one eye and can radiate outward, may be so severe that an individual suffering from a cluster headache is unable to sit or lie still.
In a clinical trial, patients who received Emgality experienced an average of 8.7 fewer weekly cluster headache attacks compared to baseline, while those who received a placebo had 5.2 fewer attacks. The baseline was established by calculating the number of cluster headaches patients experienced over a three-week period before receiving either Emgality or the placebo.
Recommended dosing under the new indication is 300mg administered via three consecutive subcutaneous injections of 100mg each at the onset of the cluster period, and then monthly until the end of the cluster period. Patients are able to self-administer the product after receiving appropriate training.
Emgality is the first calcitonin-gene related peptide (CGRP) antagonist to receive an FDA-approved indication outside of migraine prevention.