Lilly files new class migraine drug with FDA

Eli Lilly has filed a new migraine drug, lasmiditan, with the US regulator, the first drug in its class to be reviewed as a treatment for the condition. The US pharma added that the regulator has granted its Emgality (galcanezumab) Breakthrough Designation for prevention of episodic cluster headache, building on a previous approval in another form of migraine. An oral drug, lasmiditan is a selective serotonin 5-HT1F agonist that Lilly says is distinct from other approved migraine therapies and does not cause constriction of blood vessels. Lilly noted that it is the first and only molecule in the “ditan” class under evaluation for the acute treatment of a migraine in adults. The company said it could represent the first significant innovation for the acute treatment of migraine in more than two decades. The filing for lasmiditan includes data from two phase 3 single-attack studies (SAMURAI and SPARTAN), which evaluated the safety and efficacy of lasmiditan for the acute treatment of a migraine.