FDA grants Priority Review for Eli Lilly’s sBLA for Emgality injection to prevent cluster headache

FDA has granted Priority Review for Eli Lilly’s sBLA for Emgality (galcanezumab-gnlm) injection for the preventive treatment of episodic cluster headache in adults, the company said Tuesday in a press release.

Lilly said the sBLA is based on data from a Phase 3 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.