Lilly's CGRP Monoclonal Antibody Galcanezumab Approved in China for Migraine Prevention

On January 9, the official website of the National Medical Products Administration (NMPA) showed that Eli Lilly's Galcanezumab injection was approved for marketing in China, indicated for the prevention of episodic migraine in adults.

Galcanezumab, developed by Eli Lilly and Company, is a fully human monoclonal antibody targeting calcitonin gene-related peptide (CGRP), and has received FDA Breakthrough Therapy designation. CGRP is a potent vasodilatory neuropeptide, the release levels of which significantly increase during migraine attacks. Inhibiting the activity of CGRP and its receptor (CGRPR) can alleviate headaches and prevent migraine attacks.

In September 2018, Galcanezumab was launched in the United States for the first time as a preventive treatment for migraine, under the trade name Emgality. In June 2019, the product's new indication was expanded to treat episodic cluster headaches in adults. Since its launch, Galcanezumab sales have continued to grow, with revenue reaching $651 million in 2022.

This approval is mainly based on the positive results of a Phase III CGAX study of Galcanezumab conducted among Chinese patients. The study is a prospective, global multicenter, randomized, double-blind, placebo-controlled Phase III trial, with a majority of participants being Chinese patients, aiming to evaluate the efficacy and safety of Galcanezumab in the preventive treatment of episodic migraine in adults.

For the primary endpoint of monthly headache days (MHD), results showed that the Galcanezumab treatment group was significantly superior to the placebo group. Across four key secondary endpoints evaluating the functional impact of migraine—MSQ scores (quality of life scores), 50% responder rate (proportion of patients with a ≥50% reduction in headache days from baseline), 75% responder rate, and 100% responder rate—the CGAX data also demonstrated that the treatment group outperformed the placebo group, consistent with the outcomes of major global studies completed to date.

In addition, the safety of Galcanezumab was good and consistent with previous studies; adverse events were mostly mild to moderate, with no serious adverse events or deaths reported.

Migraine is one of the most common and severe neurological disorders globally, characterized by severe throbbing vascular pain and recurring headaches. It causes sensitivity to sound and light, often accompanied by symptoms such as nausea, vomiting, and dizziness. Based on headache frequency, 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. Migraine patients experience significant impacts on their normal work and sleep, which can lead to psychological issues like depression and anxiety, and even self-harm, severely reducing their quality of life. Statistics show that migraine ranks second among causes of disability worldwide. The prevalence of migraine in China is 9.3%, resulting in a heavy disease burden.

Copyright © 2024 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reprint, please leave a message to the WeChat Official Account backend or send a message, and specify the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.