Idiopathic pulmonary fibrosis Nintedanib was approved for idiopathic pulmonary fibrosis on 15 October 2014, by the United States
Food and Drug Administration (FDA), and received a positive opinion from the
European Medicines Agency in November 2014, being approved in the European Union in January 2015. It is also approved in Canada, Japan, Switzerland, and other countries. Two replicate randomized clinical trials evaluated the efficacy and safety of nintedanib for the treatment of idiopathic pulmonary fibrosis. The primary endpoint of the study was the effect on lung function, measured by forced vital capacity. In total, 1066 patients were treated with either 150 mg nintedanib or placebo and evaluated after 52 weeks. At the end of the observation period, nintedanib reduced the decline of forced vital capacity.
Lung cancer Nintedanib was approved for combination therapy of non-small-cell lung cancer in the European Union in 2014, and is approved for this indication in other parts of the world.
Other interstitial lung diseases The drug was granted priority review designation by the FDA before being approved in the US on 6 September 2019, to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated
interstitial lung disease (SSc-ILD). It is the first FDA-approved treatment for this rare lung condition. The effectiveness of nintedanib to treat SSc-ILD was studied in a randomized, double-blind, placebo-controlled trial of 576 subjects ages 20–79 with the disease. Subjects received treatment for 52 weeks, with some subjects treated up to 100 weeks. The primary test for efficacy measured the forced vital capacity, or FVC, which is a measure of lung function, defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Those who took nintedanib had less lung function decline compared to those on placebo. The overall safety profile observed in the nintedanib treatment group was consistent with the known safety profile of the therapy. The most frequent serious adverse event reported in subjects treated with nintedanib was pneumonia (2.8% nintedanib vs. 0.3% placebo). Adverse reactions leading to permanent dose reductions were reported in 34% of nintedanib-treated subjects compared to 4% of placebo-treated subjects. Diarrhea was the most frequent adverse reaction that led to permanent dose reduction in subjects treated with nintedanib. The safety and effectiveness of nintedanib to treat chronic fibrosing interstitial lung diseases with a progressive phenotype in adults was evaluated in a randomized, double-blind, placebo-controlled study of 663 adults. The mean age of subjects was 66 years and more subjects were male (54%) than female. The primary test for effectiveness was the forced vital capacity, which is a measure of lung function. It is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. In the 52-week period, subjects received either 150 milligrams of nintedanib twice a day or a placebo. After 52 weeks, people who received nintedanib had less lung function decline compared to those on the placebo. The US
Food and Drug Administration (FDA) granted nintedanib priority review designation and breakthrough therapy designation. The FDA granted the approval of Ofev to Boehringer Ingelheim Pharmaceuticals, Inc. == Society and culture ==