WASHINGTON -- The migraine prevention drug galcanezumab (Emgality) won in adults Tuesday.
With that nod, galcanezumab, made by Eli Lilly, became the first FDA-approved drug to reduce the frequency of episodic cluster headache attacks.
"The FDA is committed to continuing to work with drug developers to bring treatments for unmet medical needs to patients," Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a statement.
Cluster headaches involve recurrent attacks of excruciating pain that may strike several times a day. They have two dominant forms: episodic -- which has a remission period of a month or longer and represents 85% to 90% of cluster headache cases -- and chronic cluster headache.
Galcanezumab, a calcitonin gene-related peptide (CGRP) antagonist , showed efficacy in double-blind that tracked changes in the mean number of cluster headaches in 106 patients from baseline to week 3.
Participants were assigned randomly to receive a monthly injection of 300 mg galcanezumab (higher than the 120-mg migraine dose) or placebo. From baseline to week 3, galcanezumab users experienced 8.7 fewer weekly cluster headache attacks, compared with 5.2 fewer attacks for placebo patients.
In a , however, galcanezumab the primary endpoint and showed no significant difference in reduced headache frequency over 3 months versus placebo.
The most common side effect seen in galcanezumab trials was injection site reaction. The overall safety profile seen in episodic cluster headache patients was consistent with that seen in migraine patients. Two patients during the episodic cluster headache study because of adverse events.
Galcanezumab carries a risk of hypersensitivity reaction (rash, hives, and shortness of breath) and is contraindicated in patients with serious hypersensitivity to galcanezumab or its excipients. Hypersensitivity reactions can happen days after administration and may be prolonged; treatment should be stopped if a serious reaction occurs.