Eli Lilly intends to submit a supplemental biologics license application to the FDA for galcanezumab for the preventive treatment of episodic cluster headache by the end of 2018.
Robert Conley, MD
Eli Lilly and Company announced that the FDA granted breakthrough therapy designation to galcanezumab-gnlm (Emgality) for episodic cluster headache and intends to submit a supplemental biologics license application by the end of the year.1
A phase 3 trial, one of the first placebo-controlled studies performed in cluster headache, demonstrated that monthly injections of galcanezumab, a calcitonin gene-related peptide (CGRP), led to a significant reduction in the frequency of cluster headache attacks within the first 3 weeks.
"People with migraine and cluster headache can miss out on significant moments in their lives—birthdays, anniversaries, business meetings—and there remains an unmet need for treatment options that can help patients achieve significant reductions in the overall frequency of migraine headaches and cluster headache attacks," said Robert Conley, MD, a Distinguished Lilly Scholar and Lilly global development leader for migraine therapeutics, in a statement.2
The study was a randomized, double-blind, placebo-controlled global trial that evaluated the safety and efficacy of galcanezumab 300 mg once-monthly administered subcutaneously compared with placebo in 106 participants with episodic cluster headache who had an average of 17.5 cluster headache attacks per week at baseline. More than 80% of the participants were men, and the group had an average age of 46 years.
The findings, presented at the 60th
Annual Meeting of the American Headache Society, showed that across weeks 1 to 3 of the 2-month study period, the group treated with 300-mg galcanezumab reported a statistically significant difference in the reduction of weekly cluster headache attacks compared to placebo (-8.7 reduction for galcanezumab vs. -5.2 reduction for placebo; P
= .036). In regard to the secondary endpoint, a statistically significant greater percentage of patients in the intervention arm (76%) achieved ≥50% reduction in weekly cluster headache attacks compared to placebo (57%) (P
= .04) at week 3. Additionally, on the Patient Global Impression of Improvement scale, 73% of participants treated with the CGRP-inhibitor reported improvements by week 4, compared to 46% treated with placebo (P
= .016). The study proved efficacious in comparison to placebo for those who both did and did not fail ≥2 prior therapies.
The safety and tolerability findings were consistent with previous studies of galcanezumab. In total, 8% of the treatment group and 21% of the placebo group discontinued treatment. Additionally, 4% of participants treated with galcanezumab and 2% treated with placebo discontinued due to adverse effects. Due to a lack of efficacy, discontinuations were prompted in 2% of participants in the intervention arm compared to 14% treated with placebo.
Emgality was previously approved in September 2018 for the preventive treatment of migraine in adults as a once-monthly, self-administered, subcutaneous injection.
1.Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine, Receives Breakthrough Therapy Designation for Emgality™ (galcanezumab-gnlm) for Prevention of Episodic Cluster Headache [news release]. Indianapolis, IN: Eli Lilly and Company; Nov. 14, 2018. https://investor.lilly.com/news-releases/news-release-details/lilly-submits-new-drug-application-fda-lasmiditan-acute