The Food and Drug Administration (FDA) has approved Ofev (nintedanib; Boehringer Ingelheim) for the treatment of patients with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.
The approval was based on data from the 52-week, double-blind, placebo-controlled, phase 3 INBUILD trial that evaluated the efficacy and safety of nintedanib in 663 patients with progressive fibrosing ILD (PF-ILD), defined as patients with diffuse fibrosing lung disease of >10% extent on high-resolution computed tomography. The underlying clinical ILD diagnoses in groups represented in the trial were hypersensitivity pneumonitis (26%), autoimmune ILDs (26%), idiopathic nonspecific interstitial pneumonia (19%), unclassifiable idiopathic interstitial pneumonia (17%), and other ILDs (12%). Patients were randomized to receive either nintedanib 150mg twice daily or placebo. The primary end point was the annual rate of decline in forced vital capacity (FVC).
Findings from the study demonstrated nintedanib slowed lung function decline by 57% in the overall study population with a statistically significant adjusted rate of decline in FVC of -81mL per year vs -188mL per year with placebo, for a difference of 107mL per year between treatment arms (95% CI, 65 to 148; P <.001). Specifically, in patients with a usual interstitial pneumonia-like (UIP) fibrotic pattern, the nintedanib group had an adjusted rate of decline in FVC of -83mL per year vs -211mL per year in the placebo group (treatment difference: 128mL [95% CI, 71 to 186; P <.001]). The overall safety profile for nintedanib was found to be consistent with what has been previously observed in idiopathic pulmonary fibrosis studies.
“Chronic fibrosing ILDs with a progressive phenotype lead to respiratory symptoms and worsening lung function,” said Kevin Flaherty, MD, professor of medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan in Ann Arbor, Michigan, and lead investigator of the INBUILD trial. “This approval provides a therapeutic option for many patients who did not have an approved treatment until today.”
Ofev, a kinase inhibitor, is already indicated to treat idiopathic pulmonary fibrosis, and to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease.
The product is supplied as 100mg and 150mg strength capsules in 60-count bottles.
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