Boehringer Ingelheim, a leader in the pharmaceuticals industry, recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the use of nintedanib (suggested brand name OFEV®) in patients with idiopathic pulmonary fibrosis (IPF). Nintedanib is now on the fast track for approval by the EMA, as it has been granted accelerated assessment.
“Boehringer Ingelheim welcomes the decision by the CHMP,” said Professor Klaus Dugi, Chief Medical Officer of Boehringer Ingelheim, in a news release from the company. “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 European Union.”
The news comes as a result of the phase 3 INPULSIS® clinical trials published in the New England Journal of Medicine in May. CHMP recognized the data as pivotal, as the trials involved 1,066 patients from 24 countries with a broad range of IPF types, and significant improvements were identified in a majority. Adjudicated acute exacerbations decreased by 68%. Over 90% of eligible patients continued with the open-label extension trial.
“This decision is very encouraging as patients with IPF currently have very limited treatment options,” said Professor Luca Richeldi, investigator on the INPULSIS® study. “For the first time we have a drug that has consistently met the primary endpoint in two large Phase III trials, confirming the results of the Phase II trial.”
Nintedanib was recently approved by the Food and Drug Administration to treat IPF. It will be used as an oral capsule taken twice daily, which has been shown to significantly reduce decline in lung function with manageable side effects. Its mechanism of action involves targeting growth factor receptors associated with pulmonary fibrosis onset, such as platelet-derived growth factor (PDGF), fibroblast growth factor receptor (FGFR), and vascular endothelial growth factor receptor (VEGFR).
Other indications for nintedanib include cancer — which has been associated with IPF — as CHMP has also issued a positive opinion for its use with docetaxel to treat adults with locally advanced, metastatic or locally recurrent non-small cell lung cancer of adenocarcinoma tumor histology, after first-line chemotherapy.