General Information

Emgality (galcanezumab-gnlm) is a calcitonin gene-related peptide (CGRP) antagonist.

Emgality is specifically indicated for the preventive treatment of migraine in adults and for episodic cluster headache in adults.

Emgality is supplied as an injection for subcutaneous administration.

The recommended dosage of Emgality for preventative migraine is 240mg (two consecutive subcutaneous injections of 120mg each) once as a loading dose, followed by monthly doses of 120mg injected subcutaneously. If a dose of Emgality is missed, administer as soon as possible. Thereafter, Emgality can be scheduled monthly from the date of the last dose.

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

Clinical Results

FDA Approval

The FDA approval of Emgality for migraine was based on two Phase 3 clinical trials in patients with episodic migraine (EVOLVE-1 and EVOLVE-2) and one Phase 3 clinical trial in patients with chronic migraine (REGAIN).

EVOLVE-1 and EVOLVE-2 were six-month, double-blind, placebo-controlled studies that enrolled adult patients with episodic migraine (defined as 4-14 migraine headache days [MHDs] per month). REGAIN was a three-month, double-blind, placebo-controlled study that enrolled adult patients with chronic migraine (defined as at least 15 headache days per month with at least 8 MHDs per month). In all three studies, patients were randomized to receive once-monthly placebo, Emgality 120 mg after an initial loading dose of 240 mg, or Emgality 240 mg. The primary endpoint was the mean change from baseline in the number of monthly MHDs over the double-blind treatment period in the intent-to-treat study population.

EVOLVE-1 (Over Months 1 to 6 - baseline migraine headache days: Emgality 9.2, placebo 9.1)

Mean change from baseline (days): -4.7 days (N=210) for Emgality 120 mg compared to -2.8 days (N=425) for placebo (p<0.001)

EVOLVE-2 (Over Months 1 to 6 - baseline migraine headache days: Emgality 9.1, placebo 9.2)

Mean change from baseline (days): -4.3 days (N=226) for Emgality 120 mg compared to -2.3 days (N=450) for placebo (p<0.001)

REGAIN (Over Months 1 to 3 - baseline migraine headache days: Emgality 19.4, placebo 19.6)1,9

Mean change from baseline (days): -4.8 days (N=273) for Emgality 120 mg compared to -2.7 days (N=538) for placebo (p<0.001)

The FDA approval of Emgality for the treatment of episodic cluster headache was based on a randomized, 8-week, double-blind, placebo-controlled study. In the study, 106 patients were randomized 1:1 to receive once-monthly injections of Emgality 300 mg (N=49) or placebo (N=57), with a baseline number of weekly cluster headache attacks of 17.8 for Emgality and 17.3 for placebo. 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. 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 (p=0.046).