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FDA Approves Lilly’s Galcanezumab for Episodic Cluster Headache

June 7, 2019
Emgality becomes the only CGRP antibody indicated for the preventive treatment of the disorder

A PPM Brief

Eli Lilly and Company (Indianapolis, IN) announced1 FDA approval of Emgality (galcanezumab; 300 mg injection), for the treatment of episodic cluster headache, making it the first and only calcitonin gene-related peptide (CGRP) antibody approved by FDA for this indication to date. Emgality was first approved for preventive migraine by FDA in September 2018, joining the growing class of CGRP monoclonal antibodies. The new approved indication for Emgality treatment is recommended at 300 mg (administered three consecutive times as subcutaneous injections of 100 mg each) at the onset of a cluster period, and then monthly until the end of the cluster period.

Cluster headache is characterized by excruciating, debilitating pain lasting from 15 to 180 minutes, or occasionally longer. The pain is typically located around or through one eye or on the temple. A series of cluster headaches can take place over several weeks to months, and may occur once or twice per year. Attacks usually recur on the same side of the head. Several of the following related symptoms may occur: lacrimation, nasal congestion, rhinorrhea, conjunctival injection, ptosis, miosis of the pupil, or forehead and facial sweating. Nausea, bradycardia and general perspiration may present as well. Cluster headache afflicts males more than females by a 2.5 to 1 ratio and has an overall prevalence of 0.4%. Onset of clusters is usually between ages 20 and 45. There is often no family history of cluster headache.

Emgality is the only CGRP antibody indicated for the preventive treatment of migraine and the treatment of episodic cluster headache. (Source: 123RF)

“As someone impacted by cluster headache and an advocate for others living with this disease, I know firsthand the desperation that we have felt for additional treatment options that can reduce the frequency of these attacks that have such a debilitating impact on our lives,” said Bob Wold, founder of Clusterbusters (Lombard, IL), in the Lilly press release. “The approval of Emgality for the treatment of episodic cluster headache is a cause for celebration and hope.”

The approval comes after a randomized, 8-week, double-blind, placebo-controlled study evaluated Emgality’s efficacy for episodic cluster headache. Approximately 106 patients were randomized (1:1) to receive once-monthly injections of Emgality 300 mg (n = 49) or placebo (n = 57). The baseline number of weekly cluster headache attacks was 17.8 for Emgality and 17.3 for placebo. Results showed that:

  • Emgality patients experienced an average of 8.7 fewer weekly cluster headache attacks over Weeks 1 to 3 compared to 5.2 fewer weekly attacks for placebo (P = 0.036).
  • Approximately 71.4% of Emgality patients had their weekly cluster headache attacks cut in half or more from baseline at Week 3 compared to 52.6% with placebo (P = 0.046).

The safety profile for Emgality 300 mg monthly in patients with episodic cluster headache was found to be consistent with that of the Emgality 120 mg monthly counterpart in migraine patients (only two patients in the cluster headache study discontinued treatment because of adverse events). After being properly trained by a healthcare professional, patients can administer Emgality at home.

“For years, there have been few therapeutic options to offer patients for the treatment of episodic cluster headache. With today's approval, physicians are now armed with an FDA-approved medication that has the potential to help patients living with this condition by reducing the frequency of cluster attacks,” said David Kudrow, MD, director of the California Medical Clinic for Headache in Santa Monica, CA, in the Lily press release.

Last updated on: June 14, 2019
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Lilly's Emgality Joins the CGRP Club
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