Eli Lilly and Company has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (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 a 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.
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"Headache disorders like migraine and cluster headache affect each person differently, and many patients spend years cycling through different medications to effectively diagnose and treat their symptoms," said Gudarz Davar, M.D., vice president, Neurology Development, Lilly Bio-Medicines. "Lilly has spent the last 25 years researching innovative therapies to treat headache disorders, and we are thrilled to be one step closer to potentially providing new and different options with lasmiditan for the acute treatment of migraine and Emgality for the preventive treatment of episodic cluster headache."
The NDA 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 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.
"As a caregiver for someone living with chronic migraine, I know firsthand how disabling headache diseases can be," said Kevin Lenaburg, executive director of the Coalition For Headache And Migraine Patients (CHAMP). "We're excited about the new innovations in the acute treatment of migraine and the preventive treatment of migraine and episodic cluster headache, and we're thankful for Lilly's commitment to continue to investigate and hopefully bring these important new therapeutic options to market."