The application for marketing authorisation of Nintedanib, a tyrosine kinase inhibitor ( TKI ), for the treatment of idiopathic pulmonary fibrosis ( IPF ) has been validated and granted accelerated assessment by the European Medicines Agency ( EMA ).
The marketing authorisation application for Nintedanib has included results from two phase III trials with identical design, INPULSIS-1 and INPULSIS-2, which have shown Nintedanib has significantly slowed disease progression in patients with idiopathic pulmonary fibrosis.
Data from the two 52-week trials, recently published in the New England Journal of Medicine ( NEJM ), have demonstrated that Nintedanib met the primary endpoint by significantly reducing the annual decline in forced vital capacity by approximately 50% compared to patients taking placebo.
This effect on disease progression was further supported in the pooled data set by a positive signal in reducing the risk of acute exacerbations by 38% ( p=0.08 ) and a significant risk reduction in confirmed or suspected acute exacerbations by 68% ( p=0.005 ).
Nintedanib, two capsules a day, is the first targeted treatment for idiopathic pulmonary fibrosis that has consistently demonstrated to slow disease progression in idiopathic pulmonary fibrosis by significantly reducing the decline in lung function by half with a manageable side effect profile.
Nintedanib is an investigational small molecule tyrosine kinase inhibitor ( TKI ). 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 ). By blocking the signalling pathways that are involved in fibrotic processes, it is believed that Nintedanib has the potential to reduce disease progression in idiopathic pulmonary fibrosis 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.
Idiopathic pulmonary fibrosis is a chronic, progressive, severely debilitating and ultimately lethal lung disease for which there are limited treatment options.
Idiopathic pulmonary fibrosis affects as many as 14-43 people per 100,000 worldwide.
Idiopathic pulmonary fibrosis is characterised by progressive scarring of lung tissue and loss of lung function over time. Development of scarred tissue is called fibrosis.
Over time, as the tissue thickens and stiffens with scarring, the lungs lose their ability to take in and transfer oxygen into the bloodstream, and vital organs do not get enough oxygen. As a result, individuals with idiopathic pulmonary fibrosis experience shortness of breath, cough and often have difficulty participating in everyday physical activities. ( Xagena )
Source: Boehringer-Ingelheim, 2014