On Friday, February 27, 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) announced on its website that it recommends rejecting the marketing authorization application for Emgality® (galcanezumab) for the prophylaxis of episodic cluster headache in adults.
The amendment concerned an expansion of the indication to prevent attacks in adults with episodic cluster headaches. For this use, Emgality should be available as a 100 mg pre-filled syringe. Emgality is a medicine used to prevent migraines in adults who suffer from migraines at least 4 days a month.
It has been approved in the EU since November 2018. It contains the active ingredient galcanezumab and can be injected under the skin using a pre-filled syringe with 120 mg. The company applied to expand the indication to prevent episodic cluster headache attacks.
Cluster headaches cause very severe pain, typically on one side of the head around one eye. Attacks last up to 3 hours and can occur several times a day during active cluster periods that can last weeks to months. CGRP is involved in the development of headaches.
It dilates, sensitizes and inflames blood vessels in the brain. Emgality's active ingredient, galcanezumab, is a monoclonal antibody designed to bind and block CGRP, causing blood vessels to return to their normal vascular size. This stops the headache. In a pivotal study involving 106 patients with episodic cluster headaches, Emgality was compared with placebo (a dummy treatment).
The main outcome measure was a reduction in the frequency of headache attacks per week over a three-week period. The results of the study in patients with episodic cluster headaches did not clearly show that Emgality is effective in preventing attacks. The agency therefore considered that the benefits of Emgality in preventing attacks in patients with episodic cluster headaches did not outweigh the risks. Therefore, the Agency recommended rejecting the amendment to the marketing authorization. There are no implications for using Emgality for the prevention of migraines in adults. Due to the CHMP's negative recommendation, the manufacturer Eli Lilly announced that galcanezumab will not receive approval in the EU for the prophylaxis of episodic cluster headache. Lilly would very much regret this decision, especially since cluster headache is an extremely painful and stressful illness and only very few therapy options are approved in Germany or may be used according to the Medicines Directive, Paragraph IV.