Eli Lilly has filed an application in the US to market lasmiditan for the acute treatment of migraine with or without aura in adults.
Lasmiditan is described as a first-in-class, investigational, oral, centrally-penetrant, selective serotonin 5-HT1F agonist that is “structurally and mechanistically distinct” from other approved migraine therapies, and lacks vasoconstrictive activity associated with some other treatments.
If approved, the drug could represent the “first significant innovation for the acute treatment of migraine in more than two decades”, Lilly said.
The application includes data from two Phase III single-attack studies (SAMURAI and SPARTAN).
Data from the Phase III SPARTAN trial showed that at two hours following the first dose, a greater percentage of patients treated with lasmiditan were migraine pain-free compared to placebo.
Statistically significant results were observed across all three doses tested: 28.6 percent for 50mg; 31.4 percent for 100mg; 38.8 percent for 200mg and 21.3 percent for placebo.
Lilly also announced that it is gearing up to file for expanded use of Emgality to include the preventive treatment of episodic cluster headache in adults by the end of the year.
Emgality was approved to prevent migraine in adult in September, and has been awarded Breakthrough Therapy Designation for episodic cluster headache, potentially speeding up its review timeline. Currently, there are no approved preventive treatments for episodic cluster headache in the US, highlighting the significant unmet need in this area.