Galcanezumab-gnlm (Emgality, Lilly) has received FDA-approval for the preventive treatment of migraine in adults and for the treatment of episodic cluster headache in adults.
Galcanezumab-gnlm (Emgality, Lilly) was found to reduce total pain burden in a post-hoc analysis of 3 randomized, double-blind studies of patients with episodic and chronic migraine. The findings were presented virtually at the 62nd American Headache Society Congress Month and at the 72nd American Academy of Neurology Annual Meeting in April.
Galcanezumab-gnlm was approved by the FDA in September 2018 for the preventive treatment of migraine in adults. The drug selectively binds to the calcitonin gene-related peptide (CGRP) and is the only CGRP monoclonal antibody with response rates in the episodic migraine headache population of ≥50%, ≥75%, and 100% reduction from baseline in monthly migraine headache days over months 1 to 6. Galcanezumab-gnlm was approved by the FDA in June 2019 for the treatment of episodic cluster headache in adults.
"Total pain burden moves beyond the current and somewhat limited approach for describing migraine pain," said Gudarz Davar, MD, vice president, neurology development, Lilly Bio-Medicines, in a press release. "We're delighted that Emgality reduced the combined impact of migraine frequency, duration, and pain severity. We believe that viewing migraine through the lens of total pain burden provides a more holistic approach for people with migraine and doctors to discuss the personal pain experience."
Total pain burden combines the monthly frequency, duration, and pain severity of migraine, which has shown a significant association with patient functioning and quality of life, according to the press release.
Galcanezumab-gnlm was assessed versus placebo in patients with episodic migraine from 2 pooled 6-month studies (EVOLVE-1 and EVOLVE-2; Emgality n=435, placebo n=872) and chronic migraine in a 3-month study (REGAIN; Emgality n=273, placebo n=535).
Individuals treated with galcanezumab-gnlm experienced statistically fewer severity-weighted hours of pain than at baseline at each month compared with patients on placebo (p<0.0001 for each comparison), according to the analysis.
In patients with episodic migraine, treatment with galcanezumab-gnlm led to 68.6 fewer severity-weighted hours of pain per month on average than at baseline and compared with the placebo group, who experienced 36.2 fewer hours (mean difference = 32.3 fewer hours, 95% CI: 24.2 to 40.3).
For chronic migraine, the galcanezumab-gnlm cohort experienced 102.6 fewer severity-weighted hours of pain per month on average than at baseline and compared with the placebo group, who experienced 44.4 fewer hours of pain than at baseline (mean difference = 58.2 severity-weighted hours, 95% CI: 37.1 to 79.3).
"The impact of migraine is profound, and individualized management goes beyond how many days per month a person experiences migraine. Total pain burden serves as a more comprehensive measure and provides a deeper understanding for us and our patients to describe their pain," said Jessica Ailani, MD, director, MedStar Georgetown Headache Center, professor of Clinical Neurology, Georgetown University Hospital, in a press release. "As a clinician, I'm pleased that Emgality may help my patients achieve their preventive treatment goals. I am excited the results of this study show a positive impact on the cumulative burden of frequency, duration, and pain severity of migraine."
Emgality® Demonstrates Reduction in Frequency, Duration, and Pain Severity in Patients with Episodic and Chronic Migraine. Eli Lilly & Company; June 17, 2020. Accessed June 17, 2020. http://lilly.mediaroom.com/index.php?s=9042&item=138068