FDA Grants Priority Review to Galcanezumab for Episodic Cluster Headache

The US Food and Drug Administration (FDA) has granted Priority Review for the supplemental Biologics License Application (sBLA) for galcanezumab (Emgality) for the prevention of episodic cluster headache in adults.

"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 exists,” said Gudarz Davar, MD, vice president, Neurology Development, Lilly Bio-Medicines, in a statement.

Priority Review helps expedite the FDA’s review of applications that, if approved, would significantly improve the efficacy or safety of a treatment for a serious condition. The FDA aims to take action on these applications within 6 months of submission compared to the standard 10 months. In September 2018, the application for galcanezumab for the preventive treatment of episodic cluster headache was granted the FDA’s Breakthrough Therapy Designation.

This galcanezumab sBLA is supported by data from a phase 3 study of patients with episodic cluster headache. The trial included 106 patients with episodic cluster headache with an average of 17.5 cluster headache attacks per week at baseline. Patients were randomized to receive galcanezumab (300 mg once-monthly) or placebo.

The study met its primary endpoint achieving statistically significant differences in the reduction of weekly cluster headache attacks compared to placebo across weeks 1 to 3 of the 2-month treatment period.

Additionally, a statistically significantly greater percentage of patients treated with galcanezumab reached at least a 50% reduction in weekly cluster headache attacks compared to placebo, meeting the study’s secondary endpoint.

“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," added Davar.

Galcanezumab was first approved by the FDA in September 2018 for the preventive treatment of migraine in adults. The 120 mg injection is self-administered on a monthly basis. The company is currently recruiting children and adolescents ages 6 to 17 years for a phase 3 trial of galcanezumab for the prevention of migraine.