Novartis' Blockbuster Migraine Prevention Drug Erenumab Granted Clinical Trial Approval in China

Source: Pharmaceutical Insights

On August 1, the Center for Drug Evaluation of China’s National Medical Products Administration issued its latest announcement, granting implied approval for clinical trials of erenumab injection submitted by Novartis (China) Biomedical Research Co., Ltd. for the prevention of migraine in adults. Erenumab, jointly developed by Novartis and Amgen, is the first preventive migraine therapy approved by the U.S. Food and Drug Administration (FDA). It was approved for marketing in the United States last May and works by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule involved in migraine attacks. The drug was included in Clarivate’s “2018 Top Drugs to Watch” list and is poised to become a blockbuster new medicine with annual sales reaching or exceeding $1 billion by 2022.

Migraine is the most common cause of severe headaches worldwide. Individuals who frequently suffer from migraines may lose more than half of their lives to the condition. The disease deprives patients of time with their families, impairs work productivity, and affects other aspects of daily life. According to statistics from the World Health Organization (WHO), migraine is the sixth leading cause of years lost due to disability (YLD) globally. A survey by the Chinese Association for the Study of Pain found that the prevalence of migraine in China reaches 9.3%, while over 10% of the global population reports having experienced migraines. For patients frequently troubled by migraines, using preventive therapies to reduce the frequency of attacks is an important option for managing the condition.

Recent studies have found that migraine is a neurological disorder in which the pain-perceiving neural networks in the patient’s brain are abnormally activated, leading to headaches, and calcitonin gene-related peptide (CGRP) is one of the substances involved in pain generation. CGRP is present in blood vessels and nerve endings throughout the body; when released near nerves, it generates pain signals. Erenumab, jointly developed by Amgen and Novartis, is a humanized monoclonal antibody that effectively and specifically binds to CGRP receptors in the human body, thereby alleviating migraines.

▲CGRP can cause migraines (Image source: Molecular Medicine)

It is reported that erenumab has been evaluated in several large-scale, global, randomized, double-blind, placebo-controlled studies. More than 2,600 patients participated in the relevant clinical programs to assess the safety and efficacy of this drug in migraine prevention. In the LIBERTY trial, a multicenter, placebo-controlled, randomized, double-blind Phase 3b clinical study, 246 patients with episodic migraine were randomly assigned to receive either once-monthly subcutaneous injections of erenumab or placebo. During weeks 9–12 after the initiation of the clinical trial, 30.3% of patients treated with erenumab achieved at least a 50% reduction in monthly migraine days, a rate significantly higher than that observed in the control group (13.7%; p<0.002; odds ratio, 2.73). Furthermore, the study met all secondary endpoints, including changes in the number of monthly migraine days, changes in the number of days requiring acute migraine medication per month, changes in scores on the Migraine Physical Function Impact Diary (MPFID), and the proportion of patients achieving 75% and 100% response rates (defined as a ≥75% or 100% reduction in monthly migraine days compared with placebo).

These clinical trial data indicate that erenumab provides patients with a new approach to reducing the number of migraine days. Notably, the U.S. FDA has currently approved three novel antibody drugs targeting either CGRP itself or its receptor: in addition to erenumab, these include Teva’s Ajovy (fremanezumab-vfrm) and Eli Lilly’s Emgality (galcanezumab). Furthermore, the FDA has accepted the New Drug Application (NDA) for Allergan’s oral medication ubrogepant, indicated for the treatment of acute migraine in adults. Another agent, rimegepant from Biohaven, has completed Phase 3 clinical trials and is currently awaiting FDA review of its marketing application.

No CGRP inhibitors have been approved for market launch in China. A Phase 3 clinical trial of galcanezumab in patients with episodic migraine, sponsored by Eli Lilly, is currently ongoing. The approval of Novartis’ erenumab injection for clinical trials in China signifies that this novel drug is being positioned for the Chinese market, which is expected to provide new treatment options for a broad population of migraine patients.

▽Follow [WuXi AppTecDe】WeChat Official Account