Sanofi: applies to FDA for new indication for Dupixent
(CercleFinance.com) - Sanofi has said that the US FDA has agreed to review a supplemental Biologic License Application (sBLA) for Dupixent (dupilumab) as Additional Treatment for Moderate-to-Severe Uncontrolled Asthma in Children aged 6 to 11 years.
The pharmaceutical group said that data has shown that Dupixent significantly reduces asthma attacks and is the only biological drug to improve respiratory function in children with asthma, aged 6 to 11.
The FDA is expected to issue its decision on 21 October. An application for approval in the treatment of asthma in children for the same age group is expected to be submitted to regulatory authorities in the European Union in the first quarter of 2021.
Copyright (c) 2021 CercleFinance.com. All rights reserved.
The pharmaceutical group said that data has shown that Dupixent significantly reduces asthma attacks and is the only biological drug to improve respiratory function in children with asthma, aged 6 to 11.
The FDA is expected to issue its decision on 21 October. An application for approval in the treatment of asthma in children for the same age group is expected to be submitted to regulatory authorities in the European Union in the first quarter of 2021.
Copyright (c) 2021 CercleFinance.com. All rights reserved.