The FDA has approved galcanezumab (Emgality), a monoclonal antibody directed against calcitonin gene-related peptide (CGRP), for the treatment of episodic cluster headache in adults.

The effectiveness of galcanezumab has been demonstrated in a number of phase 3 studies including EVOLVE-1 and EVOLVE-2 for episodic migraine and REGAIN for chronic migraine.

“Emgality provides patients with the first FDA-approved drug that reduces the frequency of attacks of episodic cluster headache, an extremely painful and often debilitating condition,” said Dr Eric Bastings, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

“The FDA is committed to continuing to work with drug developers to bring treatments for unmet medical needs to patients.”

Patients self-administer galcanezumab by subcutaneous injection from single-use prefilled pens.

While there is a risk of hypersensitivity reactions with its use, the FDA said the most common side effect reported in the clinical trials was injection site reactions.

However, as reported in the limbic recently, there is still limited data beyond three years of use.

Galcanezumab will be considered as a new listing for chronic migraine in Australia at the July meeting of the PBAC.