Sanofi/Regenerative Dupixent treatment for children with special dermatitis has been approved by the European Union

On November 30th Regenerative and Sanofi announced that the European Commission (EC®) had extended Dupilumab's sales authority in the European Union (EU) to treat children aged 6 to 11 with severe endexual dermatitis, some of which are candidates for systematic treatment.
Dupixent became the first and only biotherapy drug approved by the EC for children with severe endexual dermatitis between the ages of 6 and 11, and the only systemic drug approved for the treatment of these patients.
Dupixent has previously been approved in the European Union to treat adult patients with adiotic dermatitis and other type 2 inflammatory diseases such as asthma, chronic sinusitis and nasal diapers.
approved, 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 ≥ weighing 60 kg, Dopixent 300 mg is given every two weeks after the initial load dose is given on the same day.
the doctor's assessment, the dose can be increased to 200 mg every two weeks for patients weighing between 15 and 60 kg.
and the EC decision is based on efficacy and safety data from a key Phase 3 clinical study.
the pediatric trial compared Dupixent's combined external corticosteroid hormone (TCS) with the efficacy and safety of severe endo-specific dermatitis in children aged 6 to 11 using TCS alone (as a placebo group).
common primary endpoint is the skin removal rate, assessed by the researchers' Global Assessment (IGA) score of 0 or 1, and the degree and severity of the disease 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 itching levels in the 0-10 range (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's dermatological quality of life index (CDLQI) of at least 6 points, as well as additional measurements from patient-oriented eczema measurements (OME) and endexual dermatitis scores (SCORAD).
16 weeks, 300 mg Dupixent (N=122) or 200 mg Dupixent (N=59) combined TC is used every four weeks in the treatment group Patients with S experienced the following changes: Improving the degree and severity of the disease: Patients treated with Dupixent every four weeks improved by an average of 82% compared to the placebo group, and patients treated with Dupixent every two weeks improved by an average of 80%.
. 70 percent of patients in the four-week treatment group achieved at least 75 percent improvement, while only 17 percent in the placebo group;
Skin Removal: 33 percent of patients treated with Dupixent every four weeks had skin problems removed or almost cleared, while 11 percent of patients treated with Dupixent every two weeks had skin problems removed or almost cleared, while 10 percent of patients treated with Dupixent were treated every two weeks.
Reduce itching: 51% of patients treated with Dupixent every four weeks had significantly reduced itching symptoms, while only 12% of patients treated with Dupixent every two weeks had significantly reduced itching symptoms, while only 13% of patients treated with Dupixent every two weeks had significantly reduced itching symptoms.
HR QoL: In the HR QoL report, 77 percent of patients treated with Dupixent every four weeks experienced clinically significant improvements, 39 percent in the placebo group, and 81 percent of patients treated with Dupixent every two weeks experienced 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.
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.
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