The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for nintedanib (suggested brand name OFEV) for the treatment of patients with idiopathic pulmonary fibrosis (IPF), according to Boehringer Ingelheim.
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 US FDA approval of nintedanib for the treatment of IPF.
IPF is a debilitating and fatal lung disease with a median survival of 2–3 years after diagnosis. It causes progressive scarring of the lungs, resulting in continual and irreversible deterioration in lung function and difficulty breathing.
“Boehringer Ingelheim welcomes the decision by the CHMP. There has been a high unmet need for effective treatments that can slow disease progression in IPF. We look forward to making nintedanib available soon to patients with IPF in the EU,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim.
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.
Nintedanib in IPF has been granted accelerated assessment by the EMA. Nintedanib, one capsule twice a day, is the first treatment for IPF that has consistently demonstrated a significant reduction in the decline in lung function and has a manageable side effect profile. More than 90% of eligible patients who participated in the INPULSIS trials opted to continue with nintedanib* treatment as part of an open-label extension trial.