Eli Lilly Submits NDA for Lasmiditan in China for Acute Treatment of Migraine

On January 29, the CDE website showed that Eli Lilly and Company submitted a marketing application in China for lasmiditan tablets (lasmiditan) for the acute treatment of migraine attacks.

Lasmiditan is a serotonin 1F (5-HT1F) receptor agonist that acts on the trigeminal nerve pathway, capable of penetrating the central nervous system to relieve migraine symptoms. It is a high-affinity, highly selective 5-HT1F receptor agonist with very low affinity for the 5-HT1B receptor, thus not causing vasoconstriction. The drug was initially developed by Eli Lilly and licensed to CoLucid in 2005. In January 2017, Eli Lilly acquired CoLucid and regained Lasmiditan.

Lasmiditan was first launched in the United States in October 2019, becoming the first 5-HT1F receptor agonist approved by the FDA. It has recently been approved for marketing in Japan for the treatment of migraines.

Eli Lilly conducted two Phase III clinical trials, named SAMURAI and SPARTAN, which were randomized, double-blind, and placebo-controlled, to evaluate the safety and efficacy of lasmiditan. The results showed that, compared with the placebo group, the proportion of patients in the lasmiditan group whose headaches completely disappeared two hours after taking the medication significantly increased. Additionally, other migraine symptoms that troubled patients the most, such as nausea and sensitivity to sound and light, were also significantly alleviated.

Migraine is a more "severe" condition than a common headache and is one of the most prevalent serious neurological diseases globally. It is characterized by severe throbbing pain and recurring headaches, sensitivity to sound and light, and often accompanied by symptoms such as nausea, vomiting, and dizziness. Based on the frequency of headaches, migraines are mainly divided into episodic migraines, with fewer than 15 headache days per month and intermittent relief, and chronic migraines, where patients suffer from headaches for more than 15 days each month. The normal work and sleep of migraine sufferers are significantly affected, leading to psychological issues like depression and anxiety, and even self-harm, resulting in a serious decline in quality of life.