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The Food and Drug Administration (FDA) has granted priority review status to the supplemental biologics license application (sBLA) for galcanezumab-gnlm (Emgality; Eli Lilly and Company, Indianapolis, IN). If approved, the sBLA will add the indication of prevention of episodic cluster headache in adults. The sBLA is based on a phase 3 study that evaluated the safety and efficacy of galcanezumab-gnlm in 106 adult patients with episodic cluster headache.
Galcanezumab is already approved for prevention of migraine in adults.
Priority review expedites the review of drug applications that, if approved, could represent significant advances in treatment for serious conditions. Cluster headache, which affects about 124 per 100,000 adults, is under-recognized and often misdiagnosed.
"Cluster headache is a severely disabling and excruciatingly painful neurological disorder,” said Gudarz Davar, MD, vice president, neurology development, Lilly Bio-Medicines. “Few treatment options are available, and only a limited body of research from rigorous clinical trials exists. 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."
Peter McAllister, MD
Winnie Pao, MD
Jeffrey L. Cummings, MD, ScD; and Kate Zhong, MD