The FDA has approved galcanezumab-gnlm injection solution (Emgality, Eli Lilly) for the treatment of episodic cluster headache in adults. It is the first FDA-approved drug to reduce the frequency of attacks of episodic cluster headache, which can be extremely painful as well as debilitating.
Cluster headaches often occur at the same time of day, for several weeks to months. Symptoms can include bloodshot eyes, excessive tearing of eyes, drooping of eyelids, runny nose and/or nasal congestion, facial sweating, restlessness, and agitation. Attacks can strike several times a day, and typically last from 15 minutes up to three hours.
The effectiveness of galcanezumab-gnlm was demonstrated in a trial comparing the drug to placebo in 106 patients. The trial measured the average number of cluster headaches per week for three weeks and compared the average changes from baseline in the groups. Patients taking galcanezumab-gnlm experienced 8.7 fewer weekly attacks than they did at baseline, compared to 5.2 fewer attacks for patients taking placebo.
Using galcanezumab-gnlm carries a risk of hypersensitivity reactions, and treatment should be discontinued if reaction occurs. Hypersensitivity reactions can occur days after administration and can be prolonged. The most common side effect reported by trial participants was injection-site reactions.
Galcanezumab-gnlm injection is self-administered. It was previously approved by the FDA in September 2018 for the preventive treatment of migraine in adults.
The FDA granted this application priority review and breakthrough designations.
Source: PR Newswire, June 4, 2019