Lilly Granted Priority Review For Headache Treatment
INDIANAPOLIS - Indianapolis-based Eli Lilly and Co. (NYSE: LLY) says one of its headache treatments is moving closer to approval. The U.S. Food and Drug Administration has granted Priority Review for a drug to be used for the preventative treatment of episodic cluster headache in adults.
Lilly says if its supplemental Biologics License Application for the drug Emgality is approved, it could potentially represent a significant advancement in treatment for a serious condition. Emgality is an injection treatment that received FDA approval in September to treat migraine in adults.
Emgality also received Breakthrough Therapy Designation from the FDA in September for the treatment of episodic cluster headache. The pharmaceutical giant says episodic cluster headache is a disabling disorder that affects about 124 per 100,000 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, vice president of neurology development at Lilly Bio-Medicines. "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."
Lilly says it is currently recruiting for Phase 3 studies to evaluate Emgality for the prevention of migraine in children and adolescents, aged six to 17.