Novartis Submits Erenumab Injection for Marketing Approval in China as First-in-Class Migraine Prevention Therapy

On April 7, the CDE website showed that Novartis's Erenumab Injection marketing application was accepted for the prevention of migraine in adults.

Erenumab is a fully human monoclonal antibody developed by Amgen and Novartis to prevent migraines by blocking the activity of calcitonin gene-related peptide (CGRP). In May 2018, Erenumab was approved by the FDA for marketing, becoming the world's first approved antibody drug targeting the CGRP receptor; it was launched in the EU in July 2018. According to pharmaceutical company financial reports, Erenumab's sales revenue in 2021 was $532 million.

In March 2021, Novartis announced positive results from the DRAGON Phase III study, achieving the primary endpoint. This was a randomized, double-blind, multicenter, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of Erenumab in the preventive treatment of chronic migraine in adults. The study enrolled a total of 557 patients, primarily centered in Asia with a majority being from the Chinese population.

The results showed that the Erenumab 70mg group significantly outperformed the placebo group in reducing the monthly migraine days (MMD) during the last four weeks of the 12-week double-blind treatment period compared to baseline, which was the primary endpoint. Additionally, the response rate of reducing monthly migraine days by more than 50% from baseline was significantly higher in the Erenumab 70mg group compared to the placebo group. Meanwhile, the safety and tolerability profile of Erenumab was similar to that of the placebo group, with no new safety issues identified.

Migraine is a common chronic neurovascular disease, characterized by recurrent, unilateral or bilateral throbbing severe headaches that often occur on one side of the head. It is accompanied by nausea, vomiting, and sensitivity to light, sound, and odors. About one-third of patients may experience neurological aura symptoms before an attack. It is defined by the World Health Organization as one of the most disabling chronic diseases. The prevalence of migraine in China is 9.3%, with over 130 million patients, making China the country with the largest number of migraine sufferers globally. Standardized preventive treatment can effectively enhance the efficacy of acute treatment, reduce the frequency and severity of attacks, and minimize the impact on work and daily life.