The European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) for use in children aged 6 to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation.
- The inflammation is characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), inadequately controlled with medium to high dose inhaled corticosteroids (ICS) and another medicinal product for maintenance treatment.
- The approval is based on Phase 3 VOYAGE trial data in 408 children with uncontrolled moderate-to-severe asthma.
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- Patients who added Dupixent to standard-of-care experienced substantially reduced rates of severe asthma attacks, with a 65% and 59% average reduction over one year compared to placebo.
- Improved lung function was observed as early as two weeks and sustained for up to 52 weeks.
- Improved asthma control, with 81% and 79% of patients reporting a clinically meaningful improvement at 24 weeks, based on disease symptoms and impact, compared to 64% and 69% of placebo patients, respectively.
- Reduced systemic corticosteroid use by 66% and 59% over one year compared to placebo.
- Sanofi SA (NASDAQ:SNY) and Regeneron Pharmaceuticals Inc (NASDAQ:REGN) are jointly developing Dupilumab under a global collaboration agreement.
- Price Action: SNY shares are up 0.30% at $54.30 during the premarket session on the last check Thursday. REGN stock closed 2.44% higher at $708.36 on Wednesday.
