Nintedanib Receives Additional Indication for Chronic Fibrosing Interstitial Lung Disease

The FDA recently approved another indication for nintedanib (Ofev), a multi-targeted tyrosine kinase inhibitor.

Nintedanib is currently approved for idiopathic pulmonary fibrosis (IPF) and to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease.

The latest indication makes nintedanib the first treatment for people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Unclassifiable ILDs, autoimmune ILDs, chronic hypersensitivity pneumonitis, sarcoidosis, myositis, sjogren’s syndrome, coal workers pneumoconiosis, and idiopathic forms of interstitial pneumonias (such as idiopathic non-specific interstitial pneumonia) are among the diseases that may develop into a progressive form of chronic fibrosing ILD.

The FDA designated nintedanib as a breakthrough therapy for chronic fibrosing ILDs with a progressive phenotype in October 2019. ILDs are made up of more than 200 disorders that can lead to pulmonary fibrosis, an irreversible scarring of lung tissue that negatively impacts lung function. Chronic fibrosing ILDs in which lung fibrosis continues to worsen are estimated to occur in 18% to 32% of patients with ILDs.

The FDA approval is based on the INBUILD trial, a phase 3 clinical trial that grouped patients based on the clinical behavior of their disease rather than the primary clinical diagnosis. The safety and tolerability profile of nintedanib was consistent with what was previously seen in IPF studies. The most common adverse reactions reported in greater than or equal to 5% of treated patients compared with placebo were diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, weight decreased, headache, hypertension, nasopharygitis, upper respiratory tract infection, urinary tract infections, fatigue, and back pain.

“Patients with a progressive form of chronic fibrosing ILDs may have symptoms that are similar to other respiratory illnesses and that may delay getting an accurate diagnosis for patients,” said Greg Cosgrove, MD, chief medical officer, Pulmonary Fibrosis Foundation, in a statement. “The new indication for nintedanib provides a therapeutic option for physicians and their patients as there is now a treatment option that can help slow the decline in lung function.”