Lilly receives FDA priority review designation for Emgality for the preventive treatment of episodic cluster headache in adults.

Eli Lilly and Company announced that the FDA has granted Priority Review for its supplemental Biologics License Application (sBLA) for Emgality (galcanezumab-gnlm) injection for the preventive treatment of episodic cluster headache in adults. Priority Review aims to expedite the review of applications for drugs that, if approved, could potentially represent a significant advancement in treatment for a serious condition.

The sBLA is based on data from a Phase III study that evaluated the safety and efficacy of Emgality (galcanezumab-gnlm) injection 300mg in 106 adult patients with episodic cluster headache. Emgality was previously granted Breakthrough Therapy Designation by the FDA in September 2018 for the preventive treatment of episodic cluster headache, indicating the significant unmet need for this debilitating condition for which there are currently no approved preventive medications.