The Food and Drug Administration (FDA) has approved Emgality (galcanezumab-gnlm; Lilly), a once-monthly preventive treatment for adult patients with migraine. Galcanezumab-gnlm is a humanized IgG4 monoclonal antibody specific for calcitonin-gene related peptide (CGRP) ligand.

The approval was based on data from 3 randomized, double-blind, placebo-controlled trials (EVOLVE-1, EVOLVE-2, REGAIN) in patients with either episodic or chronic migraine.  Results from the trials showed that treatment with Emgality was associated with significantly greater reduction in monthly migraine headache days compared with placebo. With regard to safety, the most common adverse reactions in Emgality clinical trials were injection site reactions.

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Emgality will be supplied in 120mg/mL single-dose prefilled pens as well as prefilled syringes. The treatment is intended for patient self-administration via subcutaneous injection. Prior to use, clinicians should train patients and caregivers on how to prepare and administer Emgality.

Emgality is expected to be available shortly, according to Lilly. The list price is $575 per month, or $6,900 annually. For patients with commercial insurance, Lilly is providing a patient support program that will cover the cost of Emgality for up to 12 months.

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