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.
Regeneron Pharmaceuticals and Sanofi have shared positive results from Part A of the pivotal Phase 3 trial evaluating Dupixent in patients 12 years and older with eosinophilic esophagitis (EoE), in which the trial met both co-primary endpoints.
Dupixent in patients 12 years and older with eosinophilic esophagitis (EoE) trial met both of its co-primary endpoints.
Sanofi and Regeneron Pharmaceuticals announced positive results from Part A of the pivotal Phase 3 trial evaluating Dupixent (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE).
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.
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.
Regeneron Pharmaceuticals and Sanofi got the approval from the FDA for Dupixent for certain combinations to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled.
Sanofi’s pivotal Phase 3 test of Dupixent (dupilumab) to treat moderate-to-severe atopic dermatitis in adolescents met its primary and key secondary endpoints. Sanofi said Wednesday that, in the trial, treatment with Dupixent as monotherapy significantly improved measures of overall disease severity, skin clearing, itching, and certain health-related quality of life measures. Sanofi noted that Dupixent is… Continue reading Sanofi, Regeneron explore Dupixent’s role in targeting Type 2 inflammation as an underlying cause of atopic dermatitis