EU approves Ofev (nintedanib) to treat Idiopathic Pulmonary Fibrosis-Boehringer

Boehringer Ingelheim announced that the European Commission (EC) has approved nintedanib for the treatment of Idiopathic Pulmonary Fibrosis (IPF), following an expedited review and positive CHMP opinion on 20 November 2014. Nintedanib will be marketed in the EU under the brand name Ofev. IPF is a debilitating and fatal lung disease – with a median survival of 2-3 years after diagnosis. EC approval is based on results from the replicate Phase III INPULSIS trials, involving 1,066 patients from 24 countries. INPULSIS results showed that nintedanib slowed disease progression by reducing the annual rate of decline in lung function by 50% in a broad range of IPF patient types including patients with early disease (forced vital capacity (FVC) more than 90% pred), limited radiographic fibrosis (no honeycombing) on high resolution computed tomography (HRCT) and those with emphysema. Nintedanib, only one capsule twice a day, is the first targeted treatment for IPF to consistently meet the primary endpoint in two identically designed Phase III trials. Nintedanib has been shown to significantly reduce the risk of adjudicated acute exacerbations by 68%.

Comment: Pirfenidone (Esbriet) from Intermune/Roche is a competitor to nintedanib and both Esbriet and Ofev were recently US approved to treat Idiopathic Pulmonary Fibrosis.