The United States Food and Drug Administration approved Emgality (galcanezumab-gnlm) for the treatment of episodic cluster headache.
The approval was based on the trial involving 106 patients, in which Emgality compared with placebo. The total number of cluster headaches per week was measured as the primary endpoint for three weeks. 8.7 fewer weekly clusters than those on baseline were observed in patients on Emgality compared to 5.2 fewer attacks than those on the baseline on placebo.
About episodic cluster headache:
A kind of headache which produces extreme pain and clusters. It often at the same time of the day for several months. Symptoms include bloodshot eyes, watering of eyes, eyelids drooping, runny nose, and sweating.
The product was earlier approved for the treatment of migraine. The product has received priority review and breakthrough review.