Officials with the FDA have approved nintedanib (Ofev, Boehringer Ingelheim Pharmaceuticals) oral capsules for the treatment of chronic fibrosing interstitial lung disease (ILD) with a progressive phenotype, according to a press release.
With this approval, nintedanib is the first FDA-approved treatment for this disease type. Nintedanib was previously approved to treat idiopathic pulmonary fibrosis and to slow the rate of decline in pulmonary function among patients with ILD associated with systemic sclerosis or scleroderma.
Chronic fibrosing ILD with a progressive phenotype includes a group of fibrotic lung diseases caused by different underlying diseases or conditions, including autoimmune ILD, hypersensitivity pneumonitis, and idiopathic interstitial pneumonia. Chronic fibrosing ILD causes lung scarring and results in rapid disease progression, with declining lung function over time.
The approval was based on the safety and efficacy data from a clinical study of 663 adult patients.
In the study, the mean age of patients was 66 years and more patients were male than female. Effectiveness was measured by the forced vital capacity, which is the measure of lung function defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.
Over the 52-week study period, patients received either 150 mg of nintedanib twice per day or a placebo. At the end of the study, patients who received nintedanib had less lung function decline compared with those on a placebo.
The most common treatment-related adverse effects reported in the trial were diarrhea, nausea, stomach pan, vomiting, liver problems, decreased appetite, headache, and weight loss. Nintedanib is not recommended for patients with moderate or severe liver impairment.
“The FDA continues to encourage the development of therapies for patients with limited or no treatment options,” Banu Karimi-Shah, MD, acting deputy director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “[This] approval helps to fulfill an unmet treatment need, as patients with these life-threatening lung diseases have not had an approved medication until now.”
1. FDA Approves First Treatment for Group of Progressive Interstitial Lung Diseases [news release]. FDA’s website. https://www.ncpanet.org/newsroom/news-releases/2020/03/09/community-pharmacy-an-eager-partner-in-coronavirus-containment-says-ncpa. Accessed March 10, 2020.