The approval was based on the results from a phase 3 double-blind, placebo-controlled trial that included 106 patients diagnosed with episodic cluster headaches. Patients were randomized to receive either once-monthly Emgality 300mg administered subcutaneously or placebo during an 8 week treatment period. The primary endpoint was the overall mean change from baseline (weeks 1 to 3) in the number of weekly cluster headache attacks.
Study findings showed that patients experienced statistically significant fewer weekly cluster headache attacks in the Emgality group compared to the placebo group at Week 3 (-8.7 vs -5.2; P =.036). Furthermore, a statistically significant greater percentage of patients achieved ≥50% reduction in weekly cluster headache attacks (secondary endpoint) in the Emgality group compared to placebo, at Week 3 (-71.4% vs -52.6%; P =.046).
“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 Eric Bastings, MD, 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.”
Regarding safety, the Company stated there is a risk of hypersensitivity reactions with Emgality use, while the most common adverse reactions were injection site reactions.
Emgality, a calcitonin gene-related peptide (CGRP) antagonist, was first approved in September 2018, with an indication for preventive treatment of migraine in adults. It is intended for patient self-administration and is supplied as 120mg/mL single-dose prefilled pens as well as prefilled syringes.
For more information visit Lilly.com.
This article originally appeared on MPR