Emgality, which is an advanced therapeutic approach for the neurologic disease, is claimed to be the first and only calcitonin gene-related peptide (CGRP) antibody approved by the FDA for two specific headache disorders.
In September 2018, the company first secured FDA approval for the preventive treatment of migraine in adults, while it is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
Lilly Bio-Medicines president Christi Shaw said: “Episodic cluster headache can be devastating. The approval of Emgality for the treatment of episodic cluster headache is an important milestone as it provides a new treatment option, which has been long-awaited by those impacted by this disease.”
Emgality’s efficacy was assessed for the treatment of episodic cluster headache in a randomized, eight-week, double-blind and placebo-controlled study.
The 106 patients have been randomised in the study in 1:1 to secure once-monthly injections of Emgality 300mg or placebo (N=57), with a baseline number of weekly cluster headache attacks of 17.8 for Emgality and 17.3 for placebo.
The study comprised of 106 adults who met the International Classification of Headache Disorders third edition diagnostic criteria for episodic cluster headache and had a maximum of eight attacks per day.
According to the company, the primary efficacy endpoint was the mean change from baseline in weekly cluster headache attack frequency across weeks one to three, and the secondary endpoint was the percentage of patients who achieved a response at week three.
The recommended dosage of Emgality is 300mg at the onset of the cluster period for episodic cluster headache.
Clusterbusters founder Bob Wold said: “The approval of Emgality for the treatment of episodic cluster headache is a cause for celebration and hope. On behalf of this community, we thank the FDA, Lilly, the researchers and the patients who helped to usher forward this innovative treatment.”