Tag: Dupixent

November 30, 2020 Off

 EC Approves Dupixent as the first biologic medicine for children (6-11) with severe atopic dermatitis 

By Dino Mustafić

Regeneron Pharmaceuticals and Sanofi today announced that 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.

October 29, 2019 Off

European Commission approves Dupixent for severe chronic rhinosinusitis with nasal polyposis

By Dino Mustafić

European Commission has approved a third indication for Dupixent® (dupilumab) for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. It is also approved for moderate-to-severe atopic dermatitis and severe asthma.

June 28, 2019 Off

Dupixent gets extended use for certain atopic dermatitis in adolescents

By Dino Mustafić

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has nodded for extension for Dupixent, following USFDA’s approval for nasal polyposis, enabling its approval in the European Union (EU) to also include adolescents 12 to 17 years of age with moderate-to-severe AD who are candidates for systemic therapy.