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

Ref: Sanofi | Image: The Economic Times