US FDA accepts supplemental new drug application for Ofev (nintedanib) for children and adolescents aged 6-17 years old with fibrosing interstitial lung disease

Boehringer Ingelheim

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.

Read Boehringer Ingelheim press release

Michael Wonder

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Michael Wonder

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Medicine , US , Paediatrics , Dossier