Eli Lilly files for FDA approval of migraine drug lasmiditan

Eli Lilly has filed for FDA approval of migraine drug lasmiditan. The Big Pharma is seeking approval of the 5-HT1F agonist on the strength of late-phase data showing the drug clears headache pain in two hours in some patients.

Lilly started exploring the potential for selective 5-HT1F agonists to treat migraine without affecting the human vasculature decades ago. The idea has taken some hits along the way—LY-334370 flamed out in phase 2 after causing toxicity in animals—and Lilly outlicensed IP to CoLucid in 2005. But the work moved forward at CoLucid, prompting Lilly to buy the biotech and its lead drug for $960 million.

The drug, lasmiditan, demonstrated its potential in a pair of phase 3 trials in patients suffering from acute migraines. Around one-third of patients who received lasmiditan were headache-free in two hours. With the placebo performing worse, the studies met their primary endpoints.

Both phase 3 trials also hit a raft of secondary endpoints, giving Lilly data on the effect of lasmiditan on the percentage of patients suffering from their most bothersome symptom (MBS). Depending on the trial, between two-fifths and half of patients who received lasmiditan were free from their MBS, compared to one-third, at most, in the control arm.

Researchers have since done a post-hoc analysis suggesting lasmiditan is effective in patients who respond poorly to triptans, a class of agonists for serotonin 5-HT1B and 5-HT1D receptors that is the gold-standard for migraine care.

Efficacy in a hard-to-treat subgroup could help Lilly carve out a space filled with off-patent drugs. Before doing so, Lilly will need to get FDA to approve lasmiditan in the acute treatment of migraine with or without aura in adults.

Lilly revealed its lasmiditan submission alongside news that it plans to file for approval of Emgality for the preventive treatment of episodic cluster headache in adults before the end of 2018.