Sanofi’s Dupixent (dupilumab) Receives European Commission Approval for Severe Asthma with Type 2 Inflammation

Shots:

  • The approval is based on LIBERTY ASTHMA program including two P-III (QUEST and VENTURE) & one P-IIb studies assessing Dupixent + SOC vs PBO in 2,888 adults and adolescents aged 12+ in patients with severe asthma + type 2 inflammation, characterized by raised blood eosinophils and/or fractional exhaled nitric oxide
  • Results in patients with eosinophils ≥300 cells/µliter & FeNO levels ≥25 parts/billion: reduction in severe exacerbations (67% & 65%); Improvement in lung function, @12wks. improvement in FEV1 (33% vs 16% & 30% vs 14%) (26% vs 10%), reduction in oral corticoid use @24wks. (70% vs 42%)
  • Dupixent (dupilumab,200mg & 300mg) is a biologic, targeting IL-4 & IL-13, marketed as a pre-filled syringe and has received EU’s & FDA approval for moderate-to-severe atopic dermatitis & asthma respectively

Click here to read full press release/ article | Ref: Sanofi | Image: The Economic Times