25 July 2023 - The supplemental new drug application is based on results from the InPedILD Phase III trial, which assessed dose-exposure and safety in paediatric patients aged 6-17.
Boehringer Ingelheim announced today that the US FDA accepted its supplemental new drug application for Ofev (nintedanib), investigating a potential treatment for children and adolescents between 6 to 17 years old with fibrosing interstitial lung disease.