Boehringer Ingelheim announced that the FDA has accepted for filing and granted priority review designation to its New Drug Application (NDA) for nintedanib for the treatment of idiopathic pulmonary fibrosis (IPF).
The NDA submission was based on results from two global Phase 3 studies (INPULSIS-1 and INPUSLSIS-2) evaluating the efficacy and safety of nintedanib in treatment of IPF.
Nintedanib is a small molecule tyrosine kinase inhibitor (TKI) which targets growth factors that may be involved in pulmonary fibrosis, such as the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), and platelet-derived growth factor receptor (PDGFR).
Previously in 2011, nintedanib was granted Orphan Drug designation for the treatment of IPF. It was also granted Fast Track status in June of 2013.
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