• The approval follows Breakthrough Therapy designation granted by the FDA and nintedanib* will be available to patients in the US within 10 days
• Approval based on Phase III data that show nintedanib* reduces annual decline in lung function by approximately 50%
• Nintedanib* is under review by the European Medicines Agency (EMA) and has been granted accelerated assessment
INGELHEIM, Germany--Boehringer Ingelheim announced today that the US Food and Drug Administration (FDA) has approved OFEV™ (nintedanib*) for the treatment of idiopathic pulmonary fibrosis (IPF), a debilitating and fatal lung disease, which has a median survival of 2-3 years after diagnosis. Until today there were no FDA-approved treatments for IPF. Granted Breakthrough Therapy designation during its review by the FDA, nintedanib* is the first and only tyrosine kinase inhibitor (TKI) approved to treat IPF. Nintedanib* is taken as one capsule twice daily and will be available to patients within 10 days.
"While the cause of IPF is unknown and there is no known curative treatment, the unfortunate patients confronted with the disease and physicians caring for patients in the U.S. have been anxiously awaiting FDA-approved treatments," said Ganesh Raghu, M.D., Professor of Medicine, University of Washington in the Division of Pulmonary and Critical Care Medicine and Director of Center for Interstitial Lung Diseases at University of Washington Medical Center, Seattle, WA. "In three clinical trials, nintedanib slowed lung function decline compared to placebo. This approval is a welcome development for patients and caregivers and it provides hope for those who are living with this devastating disease."
In clinical trials, nintedanib* reduced the annual decline in lung function by approximately 50%. This also included patients with early disease (forced vital capacity [FVC]>90% pred), no honeycombing on a high resolution computed tomography (HRCT) and/or concomitant emphysema. Nintedanib* is the first targeted treatment for IPF to consistently meet the primary endpoint in two identically designed Phase III clinical trials. Nintedanib* also significantly reduced the risk of adjudicated acute exacerbations‡. IPF exacerbations – events of acute respiratory worsening – can significantly impact the course of the disease. Approximately half of patients hospitalised for an acute IPF exacerbation die during hospitalisation.
The mechanism of action of nintedanib* in IPF is understood. Nintedanib*, a TKI, targets growth factor receptors involved in the mechanisms by which pulmonary fibrosis occurs. Most importantly nintedanib* inhibits the platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR). Side effects with nintedanib* can be effectively managed in most patients.
"The approval of nintedanib in the United States marks a truly significant moment in the history of IPF, and we are highly delighted to provide this new treatment to patients, their caregivers and physicians who are very much in need. Patients are at the heart of everything we do at Boehringer Ingelheim, and we continue to work with all regulatory bodies to ensure patients have access to this innovative treatment as soon as possible," said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim.
Boehringer Ingelheim announced in June 2014 that the application for marketing authorisation of nintedanib* for the treatment of IPF has been validated and granted accelerated assessment by the EMA.
*Nintedanib is currently being assessed by the European Medicines Agency (EMA) and other regulatory organisations worldwide
‡Adjudicated exacerbations was a pre-specified sensitivity analysis in the pooled data set. Time to first Investigator-reported exacerbation was a secondary endpoint which was met in TOMORROW and INPULSIS™-2 but not in INPULSIS™-1.