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On November 26, the latest announcement on the website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration showed that a new clinical trial approval by default has been granted to dupilumab injection submitted by Sanofi, intended for development to treatAdult patients with moderate to severe chronic simple lichen who have poor control after external drug treatment. Public data shows that, globally,Dupilumab Injection is currently conducting a Phase 3 clinical trial for the indication of lichen simplex chronicus, and this marks its first clinical approval in China for this indication.
Source of Screenshot: CDE official website
Chronic Simple Lichen (LSC, also known as neurodermatitis) is a common skin condition characterized by well-defined erythematous patches, often accompanied by hyperpigmentation and thickened lichenified plaques. The condition results from prolonged friction and scratching and most frequently occurs on the neck, ankles, scalp, perineum, vulva, scrotum, and extensor forearms. Although neurodermatitis is neither life-threatening nor contagious, the itching can be severe enough to disrupt sleep, sexual function, and overall quality of life. The vicious cycle of neurodermatitis—where scratching leads to more itching—is difficult to break, and the condition tends to persist chronically. It may subside after treatment but often recurs.Treatment of the DiseaseThe focus is on controlling itching and preventing scratching., and identify and eliminate factors that exacerbate symptoms and intervene。DupilumabIs the first anti- approved by the US FDAIL-4RαAntibody, by SanofiAndRegeneron（Regeneron）Joint Development. ItCanBy innovatively blocking the type 2 inflammatory pathway through the "dual targets" of IL-4 and IL-13, reducing the pathological responses of 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 a variety of inflammatory diseases.
According toClinicalTrialsOfficial Website, Sanofi and RegeneronTwo international multicenter Phase 3 clinical trials (STYLE 1 and STYLE 2) are currently underway, aiming toEvaluate the efficacy and safety of dupilumab compared with placebo in improving pruritus in patients with chronic simple lichen.
According to publicly available information from Sanofi, dupilumab has been approved globally for various indications, covering atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease in certain patients across all age groups.
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, and treatmentMaintenance treatment for adult patients with nodular prurigo, and adolescents aged 12 years and older and adults with asthma。The approval of this anti-IL-4Rα antibody for a new clinical trial in China also indicates that the product is about to initiate a new clinical study targeting patients with lichen simplex chronicus.
References:
[1] Website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China. Retrieved Nov 26, 2024, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c
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