Eli Lilly’s Emgality (galcanezumab-gnlm) Receives FDA’s Approval for Episodic Cluster Headache in Adults

Eli Lilly’s Emgality (galcanezumab-gnlm) Receives FDA’s Approval for Episodic Cluster Headache in Adults

Shots:

  • The approval is based on Episodic Cluster Headache Study assessing Emgality (SC, 300 mg) vs PBO in 106 patients in ratio (1:1) with episodic cluster headache and had a maximum of 8 attacks/day, a minimum of one attack every other day, and at least 4 attacks during the prospective 7-day baseline period 
  • Results: weekly cluster headache attacks (17.8 vs 17.3); fewer weekly cluster headache attacks over Weeks 1 to 3 (8.7 vs 5.2); weekly cluster headache attacks @3wks. (71.4% vs 52.6%); safety profile was consistent
  • Emgality is a calcitonin gene-related peptide (CGRP) Ab, targeted for Episodic Cluster Headache with its recommended dose as three consecutive SC injections each of 100 mg and has also received the US FDA’s approval for preventive treatment of migraine in adults in Sept 2018

Click here to read full press release/ article | Ref: Eli Lilly | Image: Behance