Lilly’s Emgality smashes all Phase 3 endpoints in migraine sub-population
New Phase 3 data have been revealed on Eli Lilly’s Emgality (galcanezumab-gnlm), detailing its success in meeting all of its primary and secondary endpoints as a preventive treatment for chronic and episodic migraine in patients who have previously failed to control their condition with other migraine medications.
Specifically, the indicated patient population refers to those who have found inadequate relief with two to four different standard-of-care migraine preventive medication categories, either because of efficacy or safety and tolerability reasons. Failure due to tolerability reasons was defined by as the manufacturer as “inadequate efficacy after at least two months of treatment at the maximum tolerated dose, or discontinuation of the medicine for safety/tolerability reasons.”
The data, drawn from 462 participants with chronic or episodic migraine with an assessed baseline of an average 13.2 headache days per month, showed that patients receiving Emgality saw a reduction of 4.1 days on average compared to just one with placebo. The calcitonin gene-related peptide (CGRP) antagonist also delivered statistical significance on its secondary outcomes of 50%, 75% and 100% response rates and improvements in the Migraine-Specific Quality of Life Questionnaire Role Function-Restrictive (MSQ-RFR) domain.
“Preventive treatment failure has been a common occurrence among patients with migraine,” said Dr Gudarz Davar, Vice President, Neurology Development at Lilly Bio-Medicines. “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.”
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