Priority Review Granted for Treatment of Episodic Cluster Headache in Adults
The Priority Review is set to fast-track an application of a drug that may potentially represent a significant advancement in treatment for a serious condition.
The FDA has granted Priority Review for its supplemental Biologics License Application (sBLA) for galcanezumab-gnlm (Emgality, Eli Lilly and Company) injection, a calcitonin gene-related (CGRP) antagonist, as preventive treatment of episodic cluster headaches in adults.
The sBLA is based on data from a phase 3 study, which evaluated the safety and efficacy of galcanezumab-gnlm injection 300 mg in 106 adult patients with episodic cluster headache. The FDA had previously granted Breakthrough Therapy Designation in September 2018, indicating the significant unmet need for episodic cluster headaches, which currently has no approved preventive medications.
According to the American Migraine Foundation, cluster headache or trigeminal autonomic cephalalgia (TAC) is a rare primary headache disorder that consists of severe headaches on one side of the head associated with red or teary eyes, runny or stuffy nose, sweating, or a sense of restlessness and agitation. It affects 124 per 100,000 adults, and is often under-recognized and misdiagnosed.
Galcanezumab-gnlm 120 mg injection was approved by the FDA in September 2018 for the preventive treatment of migraine, a neurologic disease of recurrent episodes of severe headache. Eli Lilly and Company is currently recruiting for Phase 3 studies evaluating galcanezumab-gnlm for preventive care in children and adolescents.
- Lilly Receives FDA Priority Review Designation for Emgality® (galcanezumab-gnlm) Injection for the Preventive Treatment of Episodic Cluster Headache in Adults [news release]. Indianapolis, Indiana. Eli Lilly and Company website. Published March 5, 2019. https://investor.lilly.com/news-releases/news-release-details/lilly-receives-fda-priority-review-designation-emgalityr. Accessed March 5, 2019.
- Cluster Headache. American Migraine Foundation. https://investor.lilly.com/news-releases/news-release-details/lilly-receives-fda-priority-review-designation-emgalityr. Accessed March 5, 2019.