Eli Lilly Submits NDA for Acute Treatment of Migraine

Eli Lilly has submitted a New Drug Application (NDA) to the FDA for lasmiditan for the acute treatment of migraine with or without aura in adults, according to a company press release.

If approved, lasmiditan would be the first significant advancement for the acute treatment of migraine in more than 2 decades, Lilly stated in the release. Lasmiditan uses a novel mechanism that selectively targets 5-HT_1F, including those expressed in the trigeminal pathway. As opposed to other therapies, lasmiditan has been designed to treat migraines without the vasoconstrictor activity.

Additionally, Lilly also received Breakthrough Therapy Designation for glacanezumab-gnlm (Emgality) for the prevention of episodic cluster headache. The company plans to submit a supplemental Biologics License Application (sBLA) to the FDA for this indication by the end of the year. Glacanezumab-gnlm was approved in September for the preventive treatment of migraine in adults.

The NDA for lasmiditan includes data from two phase 3 studies, SAMURAI and SPARTAN. Both trials evaluated the safety and efficacy of lasmiditan for the acute treatment of migraine.

According to the data, the percentage of patients who were migraine pain-free was significantly greater compared with placebo at 2 hours following the first dose of lasmiditan. Additionally, a significantly greater percentage of patients were free of their most bothersome symptom (MBS) compared with placebo at 2 hours following the first dose, meeting the key secondary endpoint of the trial. Patients chose their MBS from sensitivity to light, sensitivity to sound, or nausea, according to the study.

“Headache disorders like migraine and cluster headache affect person differently, and many patients spend years cycling through different medications to effectively diagnose and treat their symptoms,” Gudarz Davar, MD, vice president of Neurology Development at Lilly Bio-Medicines, said in a statement. “Lilly has spent the last 25 years researching innovative therapies to treat headache disorders, and we are thrilled to be 1 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 most commonly reported adverse events in the trial were dizziness, paraesthesia, somnolence, fatigue, nausea, muscle weakness, and numbness, according to Lilly.

References

Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine, Receives Breakthrough Therapy Designation for Emgality (galcanezumab-gnlm) for Prevention of Episodic Cluster Headache [news release]. Eli Lilly’s website. https://investor.lilly.com/news-releases/news-release-details/lilly-submits-new-drug-application-fda-lasmiditan-acute. Accessed November 14, 2018.