BI Receives EU OK for IPF Drug Ofev
Boehringer Ingelheim has received approval from the European Commission for Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF), a debilitating and fatal lung disease with a median survival of two to three years after diagnosis.
The US Food and Drug Administration approved Ofev (nintedanib) for the treatment of IPF in October 2014. In November 2014, the European Commission also granted European Union marketing authorization for Vargatef (nintedanib) in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer of adenocarcinoma tumour histology, after first-line chemotherapyng and often fatal lung disease.
Nintedanib* is a small-molecule tyrosine kinase inhibitor developed by Boehringer Ingelheim for IPF.9 Nintedanib, one capsule twice a day, slows disease progression by reducing the annual rate of decline in lung function by 50% in a broad range of IPF patient types. Nintedanib targets growth factor receptors, which have been shown to be involved in the mechanisms by which pulmonary fibrosis occurs. Most importantly nintedanib inhibits platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR). It is believed that nintedanib reduces disease progression in IPF and slows the decline in lung function by blocking the signaling pathways that are involved in fibrotic processes.
Source: Boehringer Ingelheim