EMA CHMP issues positive opinion for Boehringer’s nintedanib to treat IPF

The EMA committee’s positive opinion is based on pivotal data from the replicate Phase III INPULSIS trials which included about 1,066 patients from 24 countries.

Results from these trials showed that nintedanib significantly slowed disease progression in a broad range of patients with IPF.

Nintedanib (suggested brand name OFEV) has recently received approval from the US Food and Drug Administration (FDA) to treat IPF.

The trials evaluated the effect of oral nintedanib 150mg twice daily on the annual rate of decline in forced vital capacity (FVC) in patients with IPF over 52 weeks.

Boehringer Ingelheim chief medical officer professor Klaus Dugi said: "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."

IPF causes progressive scarring of the lungs, resulting in continual and irreversible deterioration in lung function and difficulty in breathing.

University of Southampton professor of Respiratory Medicine, chair of Interstitial Lung Disease and INPULSIS study investigator Luca Richeldi said: "This decision is very encouraging as patients with IPF currently have very limited treatment options.

"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."

Image: Boehringer Ingelheim’s corporate headquarters in Ingelheim, Germany. Photo: courtesy of Boehringer Ingelheim GmbH.