Eli Lilly's Oral Migraine Drug Lasmiditan Receives Regulatory Notification in China

On July 6, the official website of the National Medical Products Administration released the "Information on Pending Drug Notifications," which included Eli Lilly's lasmiditan tablets, indicated for the acute treatment of migraine attacks.

Lasmiditan is a serotonin 1F (5-HT1F) receptor agonist in the trigeminal pathway, which can penetrate the central nervous system to take effect and relieve migraine symptoms. It is a high-affinity and 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 was licensed to CoLucid in 2005. In January 2017, Eli Lilly acquired CoLucid and regained Lasmiditan. In October 2019, Lasmiditan was first launched in the United States, becoming the first 5-HT1F receptor agonist approved by the FDA. It was subsequently approved in Japan in January 2022 and in Europe in August of the same year for the treatment of migraine.

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 who experienced complete headache relief 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, also markedly disappeared.

In March 2021, Eli Lilly and Company announced the results of the China extension study (ME2) of the global Phase III clinical trial (CENTURION) evaluating 100 mg and 200 mg lasmiditan for the acute treatment of migraine attacks in adults.

CENTURION is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase III study designed to evaluate the efficacy and safety of lasmiditan for the acute treatment of migraine in adult patients with or without aura, including response consistency across four migraine attacks. The study is primarily conducted in Europe, North America, and Asia, while adopting an expanded enrollment strategy (ME2) to meet the requirements of regulatory authorities in various countries.

The results showed that in the two co-primary endpoints—the proportion of patients with pain freedom at 2 hours after the first dose and pain freedom in at least 2 out of 3 attacks—the data from the Chinese population indicated that the lasmiditan treatment group outperformed the placebo group, consistent with the main study findings. In multiple key secondary endpoints, including: pain freedom and relief at 1 hour, pain relief at 2 hours, disappearance of the most bothersome symptom (MBS), migraine-related disability and PGIC improvement, sustained pain freedom at 24 hours and use of rescue medication, sustained pain freedom at 48 hours, and pain relief at 2 hours after dosing in at least 2 out of 3 attacks, the data from the Chinese population also demonstrated that the lasmiditan treatment group was superior to the placebo group, highly consistent with the main study results.

In terms of safety, the severity of adverse events in the Chinese population was mostly mild or moderate, and the observed safety profile was generally consistent with the main study results.

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, which can lead to psychological issues like depression and anxiety, and even self-harm, severely reducing their quality of life.

Notably, Eli Lilly's new migraine drug targeting CGRP, galcanezumab (Galcanezumab), is in the phase of applying for marketing approval in China. (See:)

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