FDA okays cluster headache drug

Pearlman

FDA cleared the first-and-only calcitonin gene-related peptide (CGRP) antibody for cluster headaches.

Galcanezumab-gnlm (Emgality, Eli Lilly and Company) was already approved by FDA as a preventive treatment of migraine in adults. The new indication for Emgality injection (300 mg) treats episodic cluster headaches in adults.

“Patients with episodic cluster headache have not had an FDA-approved medication available to reduce the number of weekly attacks and Emgality helps address a significant unmet need for this debilitating headache disorder, which is often under-recognized and misdiagnosed,” Eric Pearlman, MD, senior medical director for Eli Lilly, told FormularyWatch.

“Emgality is the only CGRP-binding monoclonal antibody with over 80% of commercial lives covered nationally in the US. We hope to achieve similar access for patients with episodic cluster headache.”

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The U.S. list price of Emgality for the treatment of episodic cluster headache is the same per milligram as the migraine prevention indication: $6,900 annually during a maintenance year, Pearlman said. Emgality for episodic cluster headache is taken at the onset of the cluster period, and then monthly until the end of the cluster period and could cost more or less on an annual basis depending on the number of doses needed, he added.

Similar to Emgality for migraine, Lilly will provide copay support for commercially insured, eligible patients who download the savings card. Copay support will be in alignment with payer coverage criteria, including the completion of a prior authorization, according to Pearlman.

Emgality will be available at retail pharmacies beginning on June 17.

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The efficacy of Emgality was evaluated for the treatment of episodic cluster headache in a randomized, 8-week, double-blind, placebo-controlled study. Patients on Emgality experienced an average of 8.7 fewer weekly cluster headache attacks over Weeks 1 to 3 vs. 5.2 fewer weekly attacks for patients on placebo.

In addition, with Emgality, 71.4% of patients had their weekly cluster headache attacks cut in half or more from baseline at Week 3 vs. 52.6% of patients with placebo.

For episodic cluster headache, the recommended dosage of Emgality is 300 mg (administered as 3 consecutive subcutaneous injections of 100 mg. each) at the onset of the cluster period, and then monthly until the end of the cluster period.

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