NDA filed at FDA for lasmiditan for the acute treatment of migraine with or without aura in adults.- Eli Lilly

Eli Lilly and Company has announced the submission of a New Drug Application (NDA) to the FDA for lasmiditan for the acute treatment of migraine with or without aura in adults. Lasmiditan is an investigational, oral, centrally-penetrant, selective serotonin 5-HT1F agonist that is structurally and mechanistically distinct from other approved migraine therapies and lacks vasoconstrictive activity.

It is the first and only molecule in the "-ditan" class under evaluation for the acute treatment of migraine in adults. If approved, it could represent the first significant innovation for the acute treatment of migraine in more than two decades. Lilly also plans to submit an sBLA to the FDA for Emgality for the preventive treatment of episodic cluster headache in adults by the end of the year. The FDA has granted Breakthrough Therapy Designation to Emgality for episodic cluster headache. Breakthrough Therapy Designation is a process that is intended to expedite the development and review of drugs that treat serious or life-threatening diseases and, based on preliminary clinical evidence, may demonstrate substantial improvement over available therapies. Currently, there are no approved preventive treatments for episodic cluster headache in the U.S.

The NDA for lasmiditan includes data from two Phase III single-attack studies (SAMURAI and SPARTAN), which evaluated the safety and efficacy of lasmiditan for the acute treatment of migraine. In both studies, at two hours following the first dose of lasmiditan, the percentage of patients who were migraine pain-free was significantly greater compared to placebo. These results were significant across all studied doses. Lasmiditan also met the key secondary endpoint, with a significantly greater percentage of patients free of their most bothersome symptom (MBS) compared with placebo at two hours following the first dose. In these studies, patients chose their MBS from sensitivity to light, sensitivity to sound or nausea. The most commonly reported adverse events after lasmiditan dosing were dizziness, paresthesia, somnolence, fatigue, nausea, muscle weakness and numbness. Data from these studies were presented at the American Headache Society (AHS) annual meeting and the American Academy of Neurology (AAN) annual meeting.

Comment: Lasmiditan and Emgality represent two of three treatments in Lilly's pain portfolio. Emgality was approved by the FDA in September 2018 for the preventive treatment of migraine in adults. The portfolio also includes tanezumab, developed in partnership with Pfizer, which is currently being investigated for the treatment of osteoarthritis pain, chronic low back pain and cancer pain.