Novartis Announces NMPA Approval of Aimovig® (Erenumab) for Preventive Treatment of Migraine in Adults in China

On September 21, Novartis announced that the marketing application for Aimovig® (erenumab injection) for preventive treatment of migraine in adults has been officially approved by the National Medical Products Administration. Erenumab is the first fully human monoclonal antibody drug in China that targets the calcitonin gene-related peptide (CGRP) receptor. Study results show that, in terms of monthly migraine days, erenumab demonstrated clinically significant and substantial improvement compared to placebo, ushering in a new era for migraine treatment in China.

"Disabling Killer" Migraine: Clinical Urgent Need for Innovative Preventive Treatment Drugs

Migraine is a common chronic neurovascular disease, characterized by recurrent, unilateral or bilateral pulsating severe headaches, accompanied by other symptoms such as photophobia, phonophobia, nausea, and vomiting. The most common areas for pain occurrence are the orbital, frontal, and temporal regions, and it often occurs simultaneously in two or more areas.

Migraine is defined by the World Health Organization as the second leading cause of disability in humans, commonly occurring in young and middle-aged adults, with a higher incidence in women than in men. In China, the prevalence of migraine is 9.3%, with a female-to-male ratio of approximately 3:12, and the total number of patients is about 130 million, meaning that about 1 in every 10 people suffers from migraine. In addition to the impact of the disease itself, migraine is often accompanied by various complications, including anxiety, depression, cerebrovascular disease, sleep disorders, etc., imposing a heavy disease burden on patients.

Currently, the treatment of migraine includes acute pain-relief treatment and preventive treatment. Many migraine patients often rely solely on painkillers. Long-term and excessive use of painkillers may induce more significant side effects11, and even cause medication-overuse headaches12. Most preventive treatment drugs previously available were not specifically developed for migraine; they not only have limited efficacy and noticeable adverse reactions but also poor tolerability, leading to a high discontinuation rate13. Therefore, there is an urgent need for innovative treatments that can safely and effectively control migraines over the long term.

World's First Targeted CGRP Receptor Monoclonal Antibody, Significantly Reduces Monthly Migraine Days

As the world's first fully human monoclonal antibody targeting the CGRP receptor, Erenumab works by blocking the CGRP receptor molecules involved in the pathophysiological mechanism of migraine, and its benefits for the preventive treatment of migraine have been recognized by multiple international and domestic academic guidelines.

The DRAGON phase 3 study14, conducted in an Asian population primarily in China, showed that during the double-blind treatment period, the mean reduction in monthly migraine days from baseline was 5.98, 7.39, and 8.19 days at weeks 4, 8, and 12, respectively, in the erenumab group*, with all showing significant differences compared to the placebo group. Meanwhile, the study confirmed that the safety profile of erenumab in Chinese patients was consistent with the overall safety profile observed in global studies.

Two major academic organizations, the European Headache Federation and the American Headache Society, have separately conducted scientific evaluations of the evidence for CGRP monoclonal antibody drugs in recent years. They concluded that there is substantial evidence supporting the efficacy of erenumab and other CGRP monoclonal antibodies in preventive treatment of migraine, and they are strongly recommended with a recommendation level of 15,16.

Once-a-Month Self-Administration Significantly Improves Quality of Life for Migraine Patients

Erenumab is administered via subcutaneous injection by the patient themselves, with dosing once per month. Patients can complete the administration process within 15 seconds through simple operation, providing a more convenient disease management option for migraine sufferers. Erenumab can take effect as early as within the first week of treatment.

Since its first approval by the FDA in May 2018, Erenumab has been approved in more than 70 countries and regions worldwide, with cumulative applications exceeding 800,000 patients. In July 2022, Erenumab was introduced to the Guangdong-Hong Kong-Macao Greater Bay Area under the "Hong Kong-Macao Medicine and Device Connect" policy, benefiting over 100 patients.

About Anmowei® (Erenumab Injection)

Erenumab is a preventive treatment drug for migraines that specifically blocks the calcitonin gene-related peptide receptor (CGRP-R), which plays a key role in the pathogenesis of migraines. The safety and efficacy of erenumab in preventing migraines have been studied and evaluated in multiple large, global, randomized, double-blind, placebo-controlled trials, including four placebo-controlled Phase II and III pivotal registration clinical studies, as well as subsequent studies such as DRAGON, EMPOwER, and LIBERTY. The DRAGON and EMPOwER studies are Phase III pivotal registration studies primarily involving Asian populations, while LIBERTY focuses on episodic migraine patients who have failed 2-4 previous preventive treatments.

Editor: Muyan

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