Eli Lilly has announced that in its recent CONQUER trial, Emgality (galcanezumab-gnlm) met the primary and all key secondary outcomes for the indication of chronic and episodic migraine prevention.
The study was to evaluate the drug in patients with documented previous failures on two to four different standard-of-care migraine preventive medication categories, due to inadequate efficacy or for safety/tolerability reasons.
The CONQUER trial was a Phase III, double-blind, global study conducted in 12 countries that enrolled 462 patients with chronic or episodic migraine that had histories of documented treatment failure.
At baseline, patients had on average 13.2 monthly migraine headache days, and following a screening period and prospective baseline period, eligible patients were randomised 1:1 to Emgality 120 mg per month or placebo for three months of double-blind treatment.
In the study, treatment with Emgality reduced monthly migraine headache days by 4.1 days compared with 1.0 day with placebo.
Preventive treatment failure has been a “common occurrence” among patients with migraine, said Gudarz Davar, vice president, neurology development, Lilly Bio-Medicines.
He explained, "The CONQUER study applied strict and rigorous criteria to identify and enrol patients with chronic and episodic migraine who had failed multiple migraine preventive treatments, with the goal of understanding whether Emgality may be an effective option for patients with such significant unmet need."
Among all migraine preventive medication users, more than 40% have a history of previous preventive medication failure or of switching treatments.