FDA accepts for review supplemental Biologics Licence Application (sBLA) for dupilumab in treatment of children aged 6 to 11 years with uncontrolled moderate-to-severe asthma
The sBLA is supported by phase 3 data showing dupilumab significantly reduced severe asthma attacks and improves lung function within two weeks in this populaiton. EU regulatory submission for children aged 6 to 11 years with asthma is planned for first quarter of 2021.
Source:
Biospace Inc.
SPS commentary:
Currently, dupilumab is licensed in adults and adolescents aged 12 years and older, as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide, who are inadequately controlled with high dose inhaled corticosteroid plus another medicinal product for maintenance treatment.