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Galcanezumab-gnlm Injection (Emgality)

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Drs. Elliott and Chan report no financial relationships relevant to this field of study.

The FDA has approved the first drug to reduce the frequency of episodic cluster headache. Galcanezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand, blocking its binding to the CGRP receptor. Researchers believe CGRP plays an active role in migraine and cluster headaches. Galcanezumab was approved in September 2018 for the prevention of migraine headaches. It is distributed as Emgality.

Indication

Galcanezumab is indicated for the preventive treatment of migraine and treatment of episodic cluster headache. 1

Dosage

The recommended dose for episodic cluster headache is 300 mg (three consecutive subcutaneous injections of 100 mg) at the onset of the cluster period and then monthly until the end of the cluster period. 1 Sites of administration include the abdomen, thigh, back of upper arm, or buttocks. Galcanezumab is available as a 100 mg/mL single-dose, prefilled syringes as well as 120 mg/mL prefilled pens and syringes.

Potential Advantages

In addition to providing a new mechanism of action, galcanezumab also is the first FDA-approved drug to reduce the frequency of episodic cluster headaches.

Potential Disadvantages

The most common adverse reaction is injection site reactions (e.g., pain, erythema, and pruritus). 1 The incidence of anti-galcanezumab antibodies ranges from 4.8% to 12.5% after six to 12 months of treatment, respectively. 1 These are mostly neutralizing antibodies. The clinical significance is unclear at this time. 1

Comments

The efficacy of galcanezumab was evaluated in a randomized, eight-week, double-blind, placebo-controlled study. Subjects included those with episodic cluster headache who experienced a maximum of eight attacks per day, a minimum of one attack every other day, and at least four attacks during the prospective seven-day baseline period. 1 Subjects were excluded if they showed ECG abnormalities or presented with...