FDA Approves Galcanezumab-gnlm for Episodic Cluster Headache
Galcanezumab-gnlm (Emgality, Eli Lilly) is the first calcitonin gene-related peptide antibody approved for both migraine and episodic cluster headache in adults.
Officials with the FDA have approved galcanezumab-gnlm (Emgality, Eli Lilly) injectable solution for the treatment of episodic cluster headache in adults, according to a press release.
Galcanezumab-gnlm is a human immunoglobulin G4 monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor, which has been used as a target for migraine treatment. The drug was first approved by the FDA in September 2018 for the prevention of migraine in adults. Galcanezumab-gnlm is now the only CGRP antibody approved for both indications.
Episodic cluster headaches represent 85% to 90% of cluster headache prevalence, with approximately 250,000 adults living with the condition in the United States, according to Lilly.
In cluster headache, individuals experience an abrupt onset of severe-to-very severe pain on 1 side of the head, typically around or above the eye and/or temple. Other symptoms, such as eye redness, tearing, nasal congestion, rhinorrhea, forehead and facial sweating, miosis, ptosis and/or eyelid edema, and/or restlessness or agitation can also occur.
This approval was based on efficacy data from a clinical trial evaluating galcanezumab-gnlm for the treatment of episodic cluster headache in 106 patients. For the study, patients were randomized to receive either once-monthly injection of galcanezumab-gnlm 300 mg or a placebo. Baseline number of weekly cluster headache attacks were 17.6 for galcanezumab-gnlm and 17.3 for the placebo group.
According to the study, patients who received galcanezumab-gnlm experienced an average of 8.7 fewer weekly cluster headache attacks over weeks 1 to 3 versus 5.2 fewer weekly attacks for patients on a placebo. Additionally, treatment with galcanezumab-gnlm cut weekly cluster headache attacks in half or more from baseline at week 3 in 71.4% patients, compared with 52.6% of patients in the placebo arm.
Galcanezumab-gnlm’s safety profile observed in patients with episodic cluster headache treated with 300 mg was similar to those with migraine treated with 120 mg.
“For years, there have been few therapeutic options to offer patients for the treatment of episodic cluster headache,” David Kudrow, MD, director of California Medical Clinic for Headache, said in a statement. “With today’s approval, physicians are now armed with an FDA-approved medication that has the potential to help patients living with this condition by reducing the frequency of cluster attacks.”
The recommended dosage of galcanezumab-gnlm is 300 mg, administered as 3 consecutive subcutaneous injections of 100 mg each, at the onset of the cluster period and then monthly until the end of the cluster period, according to Lilly. The drug is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients. Patients can self-administer galcanezumab-gnlm after training by a health care professional.
FDA Approves Emgality (galcanezumab-gnlm) as the First and Only Medication for the Treatment of Episodic Cluster Headache that Reduces the Frequency of Attacks [news release]. Eli Lilly. https://investor.lilly.com/news-releases/news-release-details/fda-approves-emgalityr-galcanezumab-gnlm-first-and-only. Accessed June 5, 2019.