Novartis' Groundbreaking Migraine Drug Erenumab Approved in China for Preventive Treatment of Adult Migraine

On September 21, Novartis' Erenumab injection was approved for marketing in China, requiring only once-a-month administration 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 company financial reports, Erenumab's sales revenue in 2022 was $632 million.

In March 2021, Novartis announced positive results from the DRAGON Phase III study, achieving the primary endpoint. This is a randomized, double-blind, multi-center, 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 MMD 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 concerns identified.

Migraine is a common chronic neurovascular disease, characterized by recurrent, unilateral or bilateral pulsating severe headaches that mostly occur on one side of the head. It is often accompanied by nausea, vomiting, and sensitivity to light, sound, and odors. Approximately one-third of patients may experience neurological aura symptoms before an attack. It has been 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.

Copyright © 2023 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 reproduce it, please leave a message to the WeChat Official Account's backend or send a message, and include the name and ID of the official account.

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

Highlights

Online Live Streaming & Offline Salon

↑ Long press to scan the QR code and sign up for the event ↑