FDA Approves First Option for Progressive Interstitial Lung Diseases

The FDA has approved Ofev (nintedanib) oral capsules for the treatment of patients with chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype. This is the first available option for treatment of this group of lung diseases.

The drug was previous approved for the treatment of idiopathic pulmonary fibrosis and for use in patients with ILD associated with systemic sclerosis or scleroderma.

“The FDA continues to encourage the development of therapies for patients with limited or no treatment options,” said Banu Karimi-Shah, M.D., acting deputy director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

The safety and effectiveness of the drug were evaluated in a randomized, double-blind, placebo-controlled study of 663 adults, mean age 66 years, in which participants were randomly assigned to received either 150 mg Ofev twice daily or placebo.

After 52 weeks, those patients receiving Ofev saw less lung function decline than those receiving placebo, as measured by forced vital capacity.

The most common side effects reported with Ofev were diarrhea, nausea, stomach pain, vomiting, liver problems, decline in appetite, headache, and weight loss. Elevated liver enzymes and embryo-fetal toxicity, arterial thromboembolic events, and gastrointestinal perforation have also occurred in patients taking Ofev.

—Michael Potts

Reference:
FDA Approves First Treatment for Group of Progressive Interstitial Lung Diseases. News release. Food and Drug Administration; March 9, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-group-progressive-interstitial-lung-diseases.