New Data Demonstrate Efficacy of Investigational Drug for Episodic Cluster Headache, Migraine

Galcanezumab-gnlm (Emgality, Eli Lilly) demonstrated positive results in the treatment of patients with cluster headache and migraine, according to results from a phase 3 study and post-hoc analysis.

Galcanezumab-gnlm is a monoclonal antibody designed to bind to and reduce the overactivity of calcitonin gene-related peptide, which is believed to play a role in migraine and cluster headaches.

The study included a 2-month treatment period evaluating the safety and efficacy of galcanezumab-gnlm (300 mg, once monthly) compared with a placebo in 106 patients with episodic cluster headache. Patients in the trial experienced an average of 17.5 cluster headache attacks per week at baseline.

According to the data, patients treated with galcanezumab-gnlm showed statistically significant differences in the reduction of weekly cluster headache attacks compared with patients treated with a placebo across weeks 1 to 3, which was the primary endpoint. Additionally, the safety and tolerability profile was consistent with previous studies that evaluated galcanezumab-gnlm for the prevention of migraine.

Related Coverage: Migraine Drug Demonstrates Efficacy in Patients with Multiple Treatment Failures

Eli Lilly also announced results from a post-hoc analysis that demonstrated the efficacy of galcanezumab-gnlm in patients with episodic and chronic migraine who had previously failed preventive treatment with onabotulinumtoxinA (Botox).

The analysis is based on data from the EVOLVE-1, EVOLVE-2, and REGAIN studies. The EVOLVE-1 and EVOLVE-2 studies are 6-month phase 3 trials evaluating 2 doses of galcanezumab-gnlm in patients with episodic migraine. The REGAIN study is a 3-month trial evaluating 2 doses of galcanezumab-gnlm in patients with chronic migraine.

According to the results, the researchers found that patients treated with both doses of galcanezumab-gnlm experienced a statistically significant reduction in the average number of monthly migraine headache days and at least a 50% reduction in the number of migraine headache days compared with those who received a placebo.

Galcanezumab-gnlm is currently under review by the FDA for the prevention of migraines in adults and a decision is expected by the end of September 2018, according to Lilly.

For more extensive coverage pertaining to headaches and migraines, check out Specialty Pharmacy Times' sister site, NeurologyLive. The Clinical Focus page hosts hundreds of articles and videos, as well as the most recently released information on data and research.

Reference

AHS 2018: Lilly’s Emgality (galcanezumab-gnlm) Significantly Reduced Monthly Migraine Headache Days in Patients with Migraine Who Previously Failed Botox (onabotulinumtoxinA) [news release]. Eli Lilly’s website. https://investor.lilly.com/news-releases/news-release-details/ahs-2018-lillys-emgalitytm-galcanezumab-gnlm-significantly. Accessed June 28, 2018.

AHS 2018: Lilly Highlights Positive Phase 3 Results from Largest Controlled Preventive Trial in Episodic Cluster Headache [news release]. Eli Lilly’s website. https://investor.lilly.com/news-releases/news-release-details/ahs-2018-lilly-highlights-positive-phase-3-results-largest. Accessed June 28, 2018.