News
European Commission approves Dupixent as first and only biologic medicine for children with severe atopic dermatitis.-Sanofi + Regeneron
The European Commission (EC) has extended the marketing authorization for Dupixent (dupilumab) in the European Union (EU) to include children 6 to 11 years of age with severe atopic dermatitis who are candidates for systemic therapy. Dupixent is the only systemic medicine approved in the EU to treat these patients.
In children aged 6-11 years weighing 15 to <60 kg, dupixent 300 mg is administered as an injection under the skin (subcutaneous injection) every four weeks following the initial loading dose given as two injections 14 days apart. for those weighing>60 kg, Dupixent 300 mg is administered every two weeks following the initial loading dose given the same day. The dose may be increased to 200 mg every two weeks in patients weighing 15 to <60 kg based on physician’s assessment. dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (il-4) and interleukin-13 (il-13) proteins, and is not an immunosuppressant. data from dupixent clinical trials have shown that il-4 and il-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (crswnp).>60>60>
Condition: Atopic Dermatitis (Eczema)
Type: drug