Three late-stage trials of Lilly’s migraine drug galcanezumab have show positive results, putting the CGRP inhibitor on course to be submitted for regulatory approval.
The EVOLVE 1 and 2 and REGAIN studies found galcanezumab could cut the number of days in a month that patients suffer a migraine attack significantly compared to placebo.
Galcanezumab typically reduced the number of ‘migraine days’ by four to five per month, compared to a reduction of between two and three days with placebo.
Lilly Bio-Medicines’ president Christi Shaw said: “The impact of migraine is underestimated, with people who experience migraine attacks often missing work, family activities or social engagements.
“For patients with as few as one migraine headache day per week, this can mean more than 50 days of lost productivity a year.”
Lilly is trailing Amgen and Novartis’ CGRP inhinbitor erenumab, which is expected to be approved next year, but with galcanezumab’s new results it may be submitted for US approval later this year and thereby start to catch up with erenumab.
Lilly recently expanded its interests in migraine, acquiring US-based firm CoLucid Pharmaceuticals and its lead drug lasmiditan, a late-stage oral serotonin 5-HT 1F agonist.
