The US Food and Drug Administration (FDA) has accepted the filing of Pharmaceuticals’ new drug application for its nintedanib and has granted priority review designation for treatment of idiopathic pulmonary fibrosis.
An investigational small molecule tyrosine kinase inhibitor, nintedanib is currently being developed by Boehringer Ingelheim.
The company’s submission of the new drug application is supported by positive data from two global Phase III studies, INPULSIS-1 and INPULSIS-2, evaluating the safety and efficacy of nintedanib in treatment of idiopathic pulmonary fibrosis.
Boehringer Ingelheim Pharmaceuticals Clinical Development and Medical Affairs senior vice-president Tunde Otulana said: "If approved, nintedanib may offer a treatment option for people in the US who are living with this progressive disease, and have no approved treatment options today.
"We look forward to continuing to work closely with the FDA during this review period."
The FDA granted orphan-drug designation for nintedanib in June 2011, and fast-track designation in June 2013.
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By GlobalDataNintedanib targets growth factors, which have been shown to be potentially involved in pulmonary fibrosis, the vascular endothelial growth factor receptor, fibroblast growth factor receptor, and platelet-derived growth factor receptor.
According to Boehringer Ingelheim Pharmaceuticals, the safety and efficacy of nintedanib in the treatment of idiopathic pulmonary fibrosis has not been established.
Image: High-resolution computed tomography scans of the chest of a patient with idiopathic pulmonary fibrosis. Photo: courtesy of IPFeditor.
