Dupixent's treatment of child-like dermatitis is approved by the European Union

November 30, Regenerative And Sanofi announced that the European Commission® (EC) had extended Dupilumab's sales mandate in the European Union to treat children aged 6 to 11 with severe endexual dermatitis, a candidate for systemic treatment. Dupixent became the first and only biotherapy drug approved by the EC for children between the ages of 6 and 11 with severe specific dermatitis, and the only systemic drug approved for the treatment of these patients.Dupixent has previously been approved in the European Union for the treatment of epithelial dermatitis and other type 2 inflammatory diseases such as asthma, chronic sinusitis with nasal pythons in adult patients.According to the approval, in children between 6 and 11 years of age, the weight is between 15 and <60 kg, 300 mg Dupixent is injected every four weeks, with a 14-day interval between injections. For patients ≥ 60 kg of body weight, Dopixent 300 mg is given every two weeks after the initial load dose is given on the same day. According to the doctor's assessment, the dose can be increased to< 200 mg every two weeks for patients weighing between 15 and 60 kg.The EC's decision is based on efficacy and safety data from a key Phase 3 clinical study. The pediatric trial compared the efficacy and safety of Dupixent combined exosylsteroid hormone (TCS) with the single use of TCS (as a placebo group) for severe endexual dermatitis in children ages 6 to 11. The common primary endpoint is skin removal rates, assessed by the researchers' Global Assessment (IGA) score of 0 or 1, and the disease and severity measured by the Eczema Area and Severity Index Score (EASI-75). Secondary endpoints include an average change in EASI scores during baseline checks, and a reduction of at least 4 points in the itching level in the range of 0-10 (weekly average of the daily itching peak numerical score scale). In addition, improvements in health-related quality of life (HR QoL) are measured on the proportion of patients who report a child dermatological quality of life index (CDLQI) of at least 6 points, as well as additional measurements from patient-directed eczema measurements (POME) and endexual dermatitis scores (SCORAD).At 16 weeks, patients in the treatment group who used 300 mg Dupixent (N=122) or 200 mg Dupixent (N=59) every two weeks experienced the following changes:to improve the extent and severity of the disease: . Patients treated with Dupixent every four weeks improved by an average of 82 percent compared to the placebo group, and patients treated with Dupixent every two weeks improved by an average of 80 percent.· At least 70 percent of patients in the four-week treatment group improved at least 75 percent, while only 17 percent in the placebo group, and 75 percent of patients in the . every two-week treatment group improved at least 75 percent, while only 26 percent in the placebo group.Skin removal: . 33 percent of patients treated with Dupixent every four weeks had skin problems removed or almost cleared, up from 11 percent in the placebo group, and39 percent of patients treated with Dupixent every two weeks were cleared or almost cleared, while 10 percent in the placebo group.Reduced itching:51 percent of patients treated with Dupixent every four weeks had significantly reduced itching symptoms, while only 12 percent of patients treated with dupixent every two weeks had significantly reduced itching symptoms in .HR QoL: . In the HR QoL report, 77 percent of patients who used Dupixent every four weeks experienced clinically significant improvements, 39 percent in the placebo group, and81 percent of patients who used Dupixent every two weeks had clinically significant improvements, while 36 percent in the placebo group.· HR QoL assessed the severity of the disease and patients reported improvements in indicators such as itching and sleep, as well as in the treatment of patients with Dupixent.In addition, according to the Open Label Extension Test, the safety of Dupixent for 52 weeks was similar to that observed at week 16 for children between 6 and 11 years of age, consistent with the safety of adult and adolescent endexual dermatitis. (Sina Pharmaceutical News)source: 1.Dupixent approved in EU for atopic dermatitis in children 2.Dupixent® (dupilumab) Approved by European Commission as First and Only Biologic Pharmaceuticals for Children aged 6 to 11 Years with Severe Atopic dermat