Boehringer’s nintedanib gets European approval to treat idiopathic pulmonary fibrosis

The approval follows an expedited review and positive opinion issued by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in November 2014.

In the European Union (EU), nintedanib will now be marketed under the brand name OFEV.

Boehringer Ingelheim chief medical officer professor Klaus Dugi said: "Approval of this treatment for patients in the EU is a significant step towards meeting the substantial unmet need in IPF.

"Patients suffering from this chronic, debilitating disease can now be offered a new treatment option that has been shown to have a clinically meaningful effect on their disease.

"This approval is another milestone in Boehringer Ingelheim’s ongoing efforts with regard to innovation in rare diseases in general and our continuing research for the benefit of patients affected by such a dreadful disease as IPF in particular."

The approval is based on results from the replicate Phase III INPULSIS trials, involving 1,066 patients from 24 countries.

Results from these trials 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, limited radiographic fibrosis on high resolution computed tomography (HRCT) and those with emphysema.

University of Southampton professor of Respiratory Medicine, chair of Interstitial Lung Disease and study investigator Luca Richeldi said: "The approval of nintedanib in the EU gives patients with a life threatening illness a choice of therapy with proven efficacy.

"Clinical data demonstrate that nintedanib reduces the annual decline of lung function by approximately half. Data also showed that nintedanib reduced the risk of acute exacerbations, which can lead to hospitalisation and death."