Sanofi Announces NMPA Approval of Dupilumab for Uncontrolled COPD with Elevated Blood Eosinophils in China

Sep 27, 2024 16:09 CST Updated 16:09

Sanofi

Pharmaceutical R&D Developer

▎WuXi AppTec Content Team Report

Today(September 27)，Sanofi announcedIL-4Rα AntibodyDupilumabNew Indications for Injection ObtainedApproved by the National Medical Products Administration (NMPA) of China,For adult patients with COPD who have elevated blood eosinophils and are not well controlled.

DupilumabIs the first anti- approved by the US FDAIL-4RαAntibody, by SanofiAndCo-developed by Regeneron. ItCanBy innovatively targeting both IL-4 and IL-13 to block the type 2 inflammation pathway, reducing pathological responses associated with type 2 inflammation, and treating type 2 inflammation-related diseases mechanistically.。Studies have shown that IL-4 and IL-13 are key drivers of type 2 inflammation and play important roles in a variety of inflammatory diseases.

In China,DupilumabFirst approved by the NMPA in June 2020 for the treatment ofAdult Moderate to Severe Atopic Dermatitis, thereafter the product was successively approved for treatment in ChinaChildren aged 6 years and above but less than 12 years, and adults with moderate to severe atopic dermatitis, 6 months to 5 yearsInfants and ToddlersModerate to Severe Atopic Dermatitis, as well as treatmentMaintenance treatment for adult patients with nodular prurigo, and adolescents aged 12 years and older and adult patients with asthma。

According to publicly available information from Sanofi, dupilumab has been approved globally for various indications, covering atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis, chronic spontaneous urticaria (CSU), and chronic obstructive pulmonary disease (COPD) in certain patients across all age groups.In July this year, dupilumab was approved by the European Medicines Agency (EMA) as an add-on maintenance treatment,For adult patients with chronic obstructive pulmonary disease (COPD) who have elevated blood eosinophils and are not well controlled。This is the seventh indication for which the product has been approved globally.

According to the Sanofi press release,Dupilumab Approved in China This TimeBased on the results of two Phase 3 clinical studies (BOREAS and NOTUS studies), dupilumab showedSignificantly reduced acute exacerbations, improved lung function, and enhanced health-related quality of life.Specifically, two Phase 3 studies evaluated dupilumab inAdult patients with COPD characterized by Type 2 inflammation (i.e., blood eosinophils ≥300 cells/μL) and poor controlThe efficacy and safety in China, all patients received the best standard inhalation therapy. In terms of efficacy, the results in the dupilumab group compared with the placebo group were as follows:

Treatment for 52 weeks, COPDThe annualized rates of moderate to severe acute exacerbations were reduced by 30% and 34%, respectively.(Primary endpoint).
Lung function (pre-bronchodilator FEV1) improved from baseline by 160 mL and 139 mL at Week 12 of treatment, compared to 77 mL and 57 mL in the placebo group, respectively.These improvements were observed as early as Week 2 and persisted throughout the 52 weeks of the two studies.
Improvement in health-related quality of life (statistically significant in BOREAS, nominally significant in NOTUS), as assessed by the St. George's Respiratory Questionnaire.

Chronic Obstructive Pulmonary Disease (COPD) is a respiratory condition that damages the lungs and leads to a gradual decline in lung function.The corresponding symptoms include persistent cough, shortness of breath, and excessive mucus production, which may impair the patient's ability to perform daily activities and can subsequently lead to anxiety, depression, and sleep disorders.Due to the recurrent acute exacerbations requiring systemic glucocorticoid therapy and/or hospitalization, COPD also often imposes a significant economic burden on patients.Looking forward to the approval of Dupilumab to bring better treatment options for patients.

References:

[1] Global Leadership! The First and Only Targeted Treatment for COPD, Dupixent®, Approved in China. Retrieved Sep 27，2024. From https://mp.weixin.qq.com/s/z0RmxxyPeVdDFPX5wJYjlA

[2] EU Approved! Dupixent® Becomes the First Targeted Treatment for COPD. Retrieved July 03, 2024, from https://mp.weixin.qq.com/s/yVaQSYX2odClaScAATkJWA

This article was compiled and edited by the WuXi AppTec content team based on publicly available information. Individuals are welcome to share it on their social media feeds. For authorization to repost or other collaboration inquiries, please contact wuxi_media@wuxiapptec.com.

Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it indicate that WuXi AppTec supports or opposes these views. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.