Boehringer Ingelheim Gains FDA Breathrough Therapy Status for Pulmonary Drug Nintedanib
Boehringer Ingelheim reports that the US Food & Drug Administration (FDA) has granted Breakthrough Therapy designation for the company’s nintedanib, a drug to treat idiopathic pulmonary fibrosis (IPF). Nintedanib is an investigational therapy currently under review by the FDA and the European Medicines Agency.
The Breakthrough Therapy designation process was established by the FDA in 2012 to facilitate and expedite the development and review of treatments for serious or life-threatening conditions if preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. IPF is a debilitating and fatal lung disease that causes permanent scarring of the lungs, difficulty breathing, and decreases the amount of oxygen the lungs can supply to the major organs of the body
Nintedanib is a small-molecule tyrosine kinase inhibitor. It targets growth factor receptors, which have been shown to be potentially involved in pathomechanisms of pulmonary fibrosis, most importantly the platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR). 6,7 By blocking the signaling pathways that are involved in fibrotic processes, it is believed that nintedanib has the potential to reduce disease progression in IPF by slowing the decline of lung function Nintedanib* is also in clinical development as a treatment option for cancer, including non-small cell lung cancer, ovarian cancer, colorectal cancer, and hepatocellular carcinoma.
Source: Boehringer Ingelheim