Eli Lilly has announced that its migraine prevention drug Emgality (galcanezumab) has produced positive results in its phase 3 study in patients who have failed previous preventative treatments.
The positive results came from Lilly’s CONQUER study, which set out to evaluate the use of Emgality as a preventative treatment in patients suffering with chronic and episodic migraines, who also have documented previous failures on two to four different migraine preventative medications.
According to Lilly, the CONQUER study was started as a result of findings from prior phase 3 studies of Emgality, which showed the treatment could be useful for patients who had self-reported failures on various migraine preventative medications prior to enrolment in the study.
Lilly defined treatment failures as “inadequate efficacy after at least two months of treatment at the maximum tolerated dose, or discontinuation of the medication for safety/tolerability reasons”.
Emgality hit the primary endpoints of the study, as it demonstrated its superiority to placebo, with patients on the drug experiencing 4.1 fewer migraines per month compared to those not receiving the treatment. At the beginning of the study, patients had an average of 13.2 migraines per month.
The drug also hit all key secondary endpoints, including beating the placebo on the number of patients reporting that their migraine days had dropped by 50%, 75% and 100%. In addition to this, Emgality demonstrated patient improvement in a standard quality-of-life questionnaire, which measured the degree to which migraines limit a person’s daily social and work-related activities.
“There is a significant unmet need for patients who have failed multiple migraine preventative treatments – the CONQUER study was set up with the goal of understanding whether galcanezumab may be an effective option for this group of patients,” said Arash Tahbaz, senior medical director, Eli Lilly and Company UK and Northern Europe.
Emgality was approved in the US last September as a preventative treatment for migraine in adults, and became third in the market for this indication, following Amgen’s Aimovig and Teva’s Ajovy.
Since then, the drug also claimed the first FDA approval in the class for cluster headaches earlier this year. The CONQUER study sees Lilly continue to fight for dominance against its rivals, with Emgality and Ajovy fighting for second place after Aimovig.
Emgality is currently lagging far behind the first-in-class Aimovig, with Lilly reporting the drug brought in Q2 revenues of $34.3m compared to Amgen’s reported revenues of $83m for Aimovig.
Despite this, Lilly is continuing to push its efforts with Emgality, with hopes that the drug can catch up with its rivals as it adds on indications. Alongside the continued studies of Emgality, Lilly has pushed its marketing effort for the drug, reporting that the increase in spending in this area in the second quarter was primarily due to supporting the launch of Emgality in the US.