Boehringer Ingelheim has announced that 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).
Results from the Phase III INPULSIS trials, published in the New England Journal of Medicine in May 2014, showed that nintedanib significantly slowed disease progression in patients with IPF. The opinion follows the recent FDA approval of nintedanib for the treatment of IPF.
"This decision is very encouraging as patients with IPF currently have very limited treatment options," said INPULSIS study investigator Professor Luca Richeldi, Professor of Respiratory Medicine, Chair of Interstitial Lung Disease at the University of Southampton, UK. "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."
Dr Charles de Wet, UK Medical Director at Boehringer Ingelheim, commented: "Boehringer Ingelheim welcomes the decision by the CHMP to grant nintedanib a positive opinion. IPF is a highly debilitating disease for patients and there are currently only limited treatment options that are able to slow disease progression. We hope that we are able to make nintedanib available to these patients in the EU soon."
* Nintedanib is currently being assessed by the EMA and other regulatory organisations worldwide
