Galcanezumab Receives FDA Priority Review for Episodic Cluster Headache

Officials with the FDA have granted Priority Review to Eli Lilly’s supplemental Biologics License Application (sBLA) for galcanezumab-gnlm (Emgality) injection for the preventive treatment of episodic cluster headache in adults, according to a press release.

Galcanezumab-gnlm was approved by the FDA in September 2018 for the preventive treatment of migraine in adults. The new indication would extend its use to include patients with episodic cluster headache, for which there is no currently approved preventive medication.

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.

Cluster headache is a disorder composed of recurrent “attacks” of intense headaches on 1 side of the head, frequently associated with pain behind or around the eye, restlessness, and agitation, according to Lilly. These attacks can last between 15 and 180 minutes and occur near daily to multiple times daily during a cluster period. Individuals with episodic cluster headache represent 85% to 95% of cluster headache sufferers.

“Cluster headache is a severely disabling and excruciatingly painful neurological disorder. Few treatment options are available, and only a limited body of research from rigorous clinical trials exist,” Gudarz Davar, MD, vice president of Neurology Development at Lilly Bio-Medicines, said in a statement. “We are pleased the FDA has granted Priority Review for our sBLA, acknowledging the need for new treatments for this devastating disease and bringing us closer to potentially offering a preventive treatment option for these patients.”

The sBLA is based on data from a phase 3 study evaluating the safety and efficacy of 300 mg galcanezumab-gnlm injection in 106 adult patients with episodic cluster headache. Data presented at the American Headache Society annual meeting in June 2018 showed statistically significant differences in the reduction of weekly cluster headache attacks compared with patients treated with a placebo across weeks 1 to 3. Seventy-six percent of patients treated with galcanezumab-gnlm achieved at least a 50% reduction in weekly cluster headache attacks compared with 57% in the placebo group at week 3, according to the trial.

Additionally, the safety and tolerability profile were consistent with previous studies that evaluated galcanezumab-gnlm for the prevention of migraine.

If approved, the therapy could represent a significant advancement in the treatment of individuals living with episodic cluster headache.

Lilly is also currently recruiting for phase 3 studies evaluating galcanezumab-gnlm for the prevention of migraine in children and adolescents, according to the release.

Related: Clinical Insights: Galcanezumab for the Preventative Treatment of Migraines

References

Lilly Receives FDA Priority Review Designation for Emgality (galcanezumab-gnlm) Injection for the Preventive Treatment of Episodic Cluster Headache in Adults [news release]. Eli Lilly. https://investor.lilly.com/news-releases/news-release-details/lilly-receives-fda-priority-review-designation-emgalityr. Accessed March 5, 2019.

AHS 2018: Lilly Highlights Positive Phase 3 Results from the Largest Controlled Preventive Trial in Episodic Cluster Headache [news release]. Eli Lilly. https://investor.lilly.com/news-releases/news-release-details/ahs-2018-lilly-highlights-positive-phase-3-results-largest. Accessed March 5, 2019.