US FDA Accepts NDA filing for BI’s Nintedanib

Boehringer Ingelheim’s (BI) New Drug Application (NDA) for its investigational compound nintedanib has been accepted for filing by the US Food and Drug Administration (FDA) and granted Priority Review designation.

The application for nintedanib is currently under review for the treatment of people with idiopathic pulmonary fibrosis (IPF), a rare, progressive and fatal lung disease. There are currently no FDA-approved treatments for IPF.

The NDA package includes results from two global Phase III studies (INPULSIS-1 and INPULSIS-2) evaluating the efficacy and safety of nintedanib in the treatment of IPF.

In June 2011, nintedanib was granted orphan drug designation in the US. It is an investigational small molecule tyrosine kinase inhibitor (TKI) targeting growth factors, which have been shown to be potentially involved in pulmonary fibrosis – the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), and platelet-derived growth factor receptor (PDGFR).


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