Sanofi: esophagitis approved for children
(CercleFinance.com) - Sanofi reports that the European Medicines Agency has made its Dupixent (dupilumab) the first and only drug approved in the European Union for the treatment of eosinophilic esophagitis in young children aged 12 months and over.
This approval concerns children aged between 12 months and 11 years and weighing at least 15 kg, in the event of failure, contraindication or intolerance to conventional drug treatments, the healthcare group said.
Phase III data showed that significantly more children achieved histological remission after 16 weeks of treatment, compared with placebo, with results maintained for up to a year.
This approval complements the initial marketing authorisation granted in the EU for adults and adolescents. Dupixent is also approved for this age group in the US and Canada.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
This approval concerns children aged between 12 months and 11 years and weighing at least 15 kg, in the event of failure, contraindication or intolerance to conventional drug treatments, the healthcare group said.
Phase III data showed that significantly more children achieved histological remission after 16 weeks of treatment, compared with placebo, with results maintained for up to a year.
This approval complements the initial marketing authorisation granted in the EU for adults and adolescents. Dupixent is also approved for this age group in the US and Canada.
Copyright (c) 2024 CercleFinance.com. All rights reserved.