Emgality (galcanezumab-gnlm)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved September 2018

Specific Treatments:

preventive treatment of migraine in adults

Therapeutic Areas

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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.

Emgality is supplied as an injection for subcutaneous administration. The recommended dosage of Emgality 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.

Clinical Results

FDA Approval

The FDA approval of Emgality 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)

Side Effects

The most common adverse effect associated with the use of Emgality is injection site reactions.

 

Mechanism of Action

Emgality (galcanezumab-gnlm) is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

Additional Information

For additional information regarding Emgality or the preventative treatment of migraines please visit https://www.emgality.com/