EU's CHMP recommends approval of Ofev for Pulmonary Fibrosis-Boehringer

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Ofev (nintedanib), from Boehringer, for the treatment of patients with idiopathic Pulmonary Fibrosis (IPF). Results from the Phase III INPULSIS trials, published in the New England Journal of Medicine in May, showed that nintedanib* significantly slowed disease progression in a broad range of patients with IPF. The opinion comes after the recent FDA approval of nintedanib for the treatment of IPF.

The CHMP’s positive opinion is based on pivotal data 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: this included patients with early disease (forced vital capacity (FVC) >90% pred), limited radiographic fibrosis (no honeycombing) on high resolution computed tomography (HRCT) and those with emphysema. As well, nintedanib significantly reduced the risk of adjudicated acute exacerbations‡ by 68%. This can be crucial given that approximately 50% of patients hospitalised for an acute IPF exacerbation die during hospitalisation.