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.
Sanofi and Regeneron’s phase 3 clinical trial results announced Friday show Dupixent (dupilumab) combined with standard-of-care topical corticosteroids (TCS) in children aged 6-11 years with uncontrolled severe atopic dermatitis significantly improved disease signs, symptoms and health-related quality of life.
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.
Regeneron Pharmaceuticals on Wednesday said it got positive pivotal Phase 3 results for evinacumab, an investigational angiopoietin-like 3 (ANGPTL3) antibody, in patients with homozygous familial hypercholesterolemia (HoFH).
The European Commission (EC) has licensed Dupixent (dupilumab), developed by Regeneron and Sanofi, for older than 12 patients as an add-on maintenance treatment for severe asthma with type 2 inflammation.
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
Sanofi and Regeneron Pharmaceuticals said they will accelerate and expand investment for the clinical development of the PD-1 (programmed cell death protein 1) antibody cemiplimab in oncology and dupilumab in Type 2 allergic diseases.
Sanofi and Regeneron Pharmaceuticals got European Commission marketing authorization for Dupixent for use in adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
The pivotal Phase 3 Libery ASthma Quest study of dupilumab in a broad population of patients with uncontrolled, persistent asthma met its two primary endpoints, Sanofi and Regeneron Pharmaceuticals said Monday.
Sanofi and Regeneron Pharmaceuticals, said on Friday that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation status to cemiplimab (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, the second deadliest skin cancer after melanoma.