FDA Approves OFEV for the Treatment of Idiopathic Pulmonary Fibrosis

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Boehringer Ingelheim's OFEV was approved by FDA as the first treatment for idiopathic pulmonary fibrosis, a fatal lung disease.

Boehringer Ingelheim announced on Oct. 16, 2014 that it received FDA approval for its idiopathic pulmonary fibrosis (IPF) treatment, OFEV. According to the National Institutes of Health (NIH), IPF is a disease that causes tissue in the lungs to become scarred over time, limiting oxygen into the bloodstream. There is no cure, causing many patients to live only three to five years after diagnoses, experiencing respiratory failure, pulmonary hypertension, heart failure, pulmonary embolism, pneumonia, or lung cancer.

OFEV, or nintedanib, is the first and only tyrosine kinase inhibitor (TKI) that is FDA-approved to treat IPF. The TKI targets growth factor receptors that inhibit pulmonary fibrosis, the platelet-derived growth factor receptor, fibroblast growth factor receptor, and the vascular endothelial growth factor receptor. In clinical trials, nintedanib reduced the annual decline in lung function by approximately 50%. It also reduced the risk of acute respiratory worsening, or acute IPF exacerbation, an event in which about half of patients die while hospitalized.

“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 US have been anxiously awaiting FDA-approved treatments. 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,” said Ganesh Raghu, MD, Professor of Medicine, 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 a press release.


Also approved for the treatment of IPF is Genetech’s Esbriet.

Source: Boehringer Ingelheim