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On March 19, the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) revealed,An application for a new indication of dupilumab injection submitted by Sanofi (Sanofi) is proposed to be included in the priority review, with the proposed indication beingBullous Pemphigoid。A few days ago (March 11), Regeneron（Regeneron）Regeneron and Sanofi announced the treatment of DupilumabAdult patients with moderate to severe bullous pemphigoid (BP)The pivotal Phase 2/3 clinical trial results, which met all primary and key secondary endpoints,Patients treated with dupilumab achieved sustained relief at a rate five times higher than the placebo group.Currently, the U.S. FDA has accepted the application for dupilumab to treat adult BP and granted it priority review status.
Screenshot source:CDE Official Website
BP is a chronic and relapsing skin condition associated with underlying type 2 inflammation, commonly occurring in the elderly population. It is characterized by intense itching, blisters, redness of the skin, and painful lesions. Blisters and rashes may spread across the entire body, leading to skin bleeding and crusting, increasing the risk of infection, and impacting daily life.DupilumabIs the first anti approved by the 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 show that IL-4 and IL-13 are key drivers of type 2 inflammation and play important roles in various inflammatory diseases.
In March this year, Regeneron and Sanofi announced the pivotal Phase 2/3 clinical trial at the 2025 American Academy of Dermatology (AAD) Annual Meeting.ADEPTResults.The ADEPT trial enrolled a total of 106 adult patients with moderate to severe BP, who were randomly assigned to receive treatment every two weeks on the basis of oral corticosteroid (OCS) therapy.Dupilumab(n=53) or placebo (n=53) treatment. The definition of sustained disease remission isCompleted OCS tapering regimen within 16 weeks without recurrence and did not use rescue therapy during the 36-week treatment period.。At 36 weeks,DupilumabResults for the treatment group compared to the placebo group are as follows:
20% of patients achieved sustained disease remission, compared to only 4% in the placebo group;
40% of patients experienced a ≥90% reduction in disease severity., while the placebo group was 10%;
40% of patients achieved clinically meaningful reductions in itching, compared to 11% in the placebo group;
DupilumabTreatment GroupAverage cumulative OCS exposure reduced by 1678 mg, the risk of remedial drug use was reduced by 54%.
In this elderly population,DupilumabThe overall incidence of adverse events in the treatment group and the placebo group was 96% (n=51).。DupilumabNo deaths due to adverse events occurred in the treatment group, while there were 2 cases of death due to adverse events in the placebo group.
Public information shows that DupilumabHas received regulatory approval for one or more indications in more than 60 countries and regions worldwide, including atopic dermatitis (AD) across all age groups, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis (PN), chronic spontaneous urticaria (CSU), and chronic obstructive pulmonary disease (COPD).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 treatmentAdults with prurigo nodularis, maintenance treatment for adolescents aged 12 years and above and adults with asthma, adult patients with chronic obstructive pulmonary disease (COPD) who have elevated blood eosinophils and are not well controlled.
This timeDupilumab is proposed for priority review in China for a new indication, which means that the product is expected to benefit more patients at an accelerated pace.
References:
[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved Mar 19，2025, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c
[[2] Global Leader! The First and Only Targeted Treatment for COPD, Dupixent®, Approved in China. Retrieved Sep 27，2024. From https://mp.weixin.qq.com/s/z0RmxxyPeVdDFPX5wJYjlA[3] Dupixent® (dupilumab) Late-Breaking Positive Pivotal Data in Bullous Pemphigoid Presented at AAD. Retrieved March 10, 2025, from https://www.globenewswire.com/news-release/2025/03/08/3039374/0/en/Dupixent-dupilumab-Late-Breaking-Positive-Pivotal-Data-in-Bullous-Pemphigoid-Presented-at-AAD.htmlThis 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 circles. For re-posting authorization or other collaboration inquiries, please contact wuxi_media@wuxiapptec.com.
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