First Treatment for Chronic Fibrosing Interstitial Lung Diseases Granted FDA Approval

The FDA has approved nintedanib (Ofev, Boehringer Ingelheim) oral capsules for patients with chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype.

Chronic fibrosing ILD with a progressive phenotype encompasses a group of fibrotic lung diseases caused by various underlying diseases or conditions, including autoimmune ILD, hypersensitivity pneumonitis, and idiopathic nonspecific interstitial pneumonia. Characteristics include lung scarring, and rapid disease progression, as determined through worsening lung function tests, symptoms, and/or imaging. Progressive lung scarring leads to breathlessness and respiratory failure, and can be debilitating and life-threatening over time.

The safety and efficacy of nintedanib was established in a randomized, double-blind, placebo-controlled study of 663 adults, with a mean age of 66 years old. The primary test for effectiveness was the first vital capacity, the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.

During the 52-week study period, patients received either 150 mg of nintedanib twice daily or a placebo. After 52 weeks, patients who received nintedanib saw less decline in lung function compared with those who received the placebo.

The most commonly reported adverse effects included diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, and weight loss. The drug is not recommended for patients with moderate to severe hepatic impairment.

Nintedanib also received FDA Priority Review and Breakthrough Therapy Designation. It 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.

REFERENCE

FDA Approves First Treatment for Group of Progressive Interstitial Lung Diseases [news release]. White Oak, MD; March 9, 2020. FDA website, https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-group-progressive-interstitial-lung-diseases. Accessed March 9, 2020.