FDA approves Ofev for chronic fibrosing interstitial lung diseases.- Boehringer

The FDA has approved Ofev (nintedanib) oral capsules, from Boehringer, to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait). It is the first FDA-approved treatment for this group of fibrosing lung diseases that worsen over time. Chronic fibrosing ILD with a progressive phenotype encompasses a group of fibrotic lung diseases caused by different underlying diseases or conditions, including autoimmune ILD, hypersensitivity pneumonitis and idiopathic nonspecific interstitial pneumonia. Characteristics of chronic fibrosing ILD include lung scarring and rapid disease progression, as assessed through worsening lung function tests, symptoms and/or imaging. Progressive lung scarring leads to breathlessness and respiratory failure. Lung function declines over time among these patients and can be debilitating and life-threatening.Ofev's safety and effectiveness to treat chronic fibrosing ILD with a progressive phenotype in adults was evaluated in a randomized, double-blind, placebo-controlled study of 663 adults. The mean age of patients was 66 years and more patients were male (54%) than female. The primary test for effectiveness was the forced vital capacity, which is a measure of lung function. It is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. In the 52-week period, patients received either 150 milligrams of Ofev twice a day or a placebo. After 52 weeks, people who received Ofev had less lung function decline compared to those on the placebo. The most common side effects reported in the Ofev clinical trial were diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache and weight loss.Comment: Ofev 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.