Galcanezumab-gnlm Demonstrates Clinically Meaningful Efficacy, Safety in 3 Months for Migraine

Galcanezumab-gnlm (Emgality; Eli Lilly and Company) did not meet the primary endpoint of statistical superiority to rimegepant orally disintegrating tablet (Nurtec ODT) on the percentage of individuals achieving a 50% or greater reduction in monthly migraine headache days, according to results of the CHALLENGE-MIG (NCT05127486) clinical trial.¹

Credit: Oleksii - stock.adobe.com

Investigators reported that the response rates were similar; however, galcanezumab-gnlm did demonstrate clinically meaningful efficacy and safety in the 3-month study, which was consistent with previous data of 6-month studies.¹

"These results bolster our knowledge of [galcanezumab-gnlm’s] ability to work quickly and help patients improve their quality of life with less frequent dosing," Anne White, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience, said in a statement. "Reducing the frequency of migraine headache days can help [patients] experience more freedom from the burden of this debilitating neurological disease and get back to participating in the daily activities that matter most to them."¹

Additionally, investigators determined that galcanezumab-gnlm performed numerically better on key secondary endpoints during the 3-month trial.¹

The safety profiles of both medications were consistent with those previously reported, and no new safety signals were identified. The company plans on releasing the full results later this year.¹

The CHALLENGE-MIG study was the first and only trial of its kind to compare 2 CGRP antagonist therapies, according to a statement.¹

The study was a 3-month, double-blind clinical trial that assessed the efficacy and safety of galcanezumab-gnlm compared to rimegepant in the prevention of episodic migraine in adults. Investigators randomized 580 individuals to either 4 injections of galcanezumab-gnlm 120 mg, with a loading dose of 2 injections followed by 2 additional monthly injections, and a placebo, or 45 doses of rimegepant 75 mg, with 1 tablet every other day, and a placebo injection. Both doses are the regulatory approved dosages.¹

"Despite being the third most common disease worldwide, migraine remains largely under-diagnosed and under-treated," Peter Goadsby, MBBS, MD, PhD, from King's College London and University of California Los Angeles, said in the statement. "These results reinforce the impact that innovative medicines can have in the prevention of migraine."¹

Galcanezumab-gnlm is a monoclonal antibody that inhibits the effects of calcitonin gene-related peptide (CGRP) by binding directly and is injectable. Rimegepant binds to and blocks the CGRP receptors and is administered orally.¹

Galcanezumab-gnlm is indicated for the preventive treatment of migraine and treatment of episodic cluster headache in adults.¹ Approximately 4.3% of adults aged 18 years and older reported being bothered by headache or migraine in the past 3 months in 2021, according to the CDC. The percentage of women was 6.2% compared to 2.2% for men.²

According to the CDC, this was true in all age groups, with 7.4% of women aged 18 to 44 years and 2.4% for men, 6.7% compared to 2.44% for those aged 45 to 64 years, and 3.1% compared to 1.5% for those aged 65 years and older, respectively.²

Reference

1. First-Of-Its-Kind Head-to-Head Clinical Trial Reaffirms the Efficacy of Emgality in Episodic Migraine Prevention. News release. Eli Lilly and Company. June 16, 2023. Accessed June 20, 2023. https://investor.lilly.com/news-releases/news-release-details/first-its-kind-head-head-clinical-trial-reaffirms-efficacy
2. QuickStats. Percentage of adults aged ≥18 years who have been bothered a lot by headache or migraine in the past 3 months, by sex and age group. CDC MMWR Morb Mortal Wkly Rep. Updated June 1, 2023. Accessed June 20, 2023. http://dx.doi.org/10.15585/mmwr.7222a6