The European Medicines Agency (EMA) has recommended extending the licence of dupilumab (Dupixent) to include the indication of add-on maintenance treatment for severe asthma with type 2 inflammation.
The EMA recommends that in addition to its current indication for moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy, dupilumab should be approved as add-on maintenance therapy in adults and adolescents (12 years and older) with severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised exhaled nitric oxide (FeNO), which are inadequately controlled with high-dose inhaled corticosteroid plus other maintenance treatment.
The decision follows the publication of results from the Liberty Asthma Quest trial (n=1,902) which reported that dupilumab 200 mg every two weeks was associated with a 47.7 per cent lower annualised rate of severe asthma exacerbations compared with placebo. Among patients with a blood eosinophil count of ≥300/mm3, the annualised severe exacerbations rate was 65.8 per cent lower.
Blood eosinophilia occurred after the start of the intervention in 4.1 per cent of participants who received dupilumab, compared with 0.6 per cent who received placebo.
The EMA recommendation will now be sent to European Commission for final approval.