FDA Approves New Treatment for Chronic Fibrosing ILD

March 10, 2020

The U.S. Food and Drug Administration has approved the first-ever treatment for chronic fibrosing interstitial lung disease (ILD), a condition that can affect rheumatoid arthritis patients. The treatment is designed for patients with a form of the disease that progressively worsens over time.

The U.S. Food and Drug Administration has approved the first-ever treatment for chronic fibrosing interstitial lung disease (ILD), a condition that can affect rheumatoid arthritis patients. The treatment is designed for patients with a form of the disease that progressively worsens over time.

The new treatment, Ofev by Boehringer Ingelheim (nintedanib), is an oral treatment currently approved for the treatment of idiopathic pulmonary fibrosis (IPF) and in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). The approved recommended dosage is 150 mg twice daily approprixmately 12 hours apart with food, but also 100 mg dosages are available for dose reduction treatment to manage adverse reactions.

Lung scarring caused by chronic fibrosing ILD can be a life-threatening condition due to respiratory failure. Chronic fibrosing ILD applies to a group of fibrotic lung diseases caused by different underlying diseases or conditions, including autoimmune ILD, hypersensitivity pneumonitis and idiopathic nonspecific interstitial pneumonia. Chronic fibrosing ILD is marked by lung scarring and rapid disease progression.

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"Interstitial lung disease (ILD) is the most common manifestation of rheumatoid lung disease," according to Fiona R. Lake, M.D., writing in UpToDate. "Rheumatoid arthritis-associated interstitial lung disease (RA-ILD) is not a single type of ILD, but rather is composed of a spectrum of histologic types with different associated patterns of clinical presentation, radiographic features, response to treatment, and clinical course."

Ofev is a small molecule that is an inhibitor of fibroblast growth factor receptor (FGFR)-1 and vascular endothelial growth factor receptor (VEGFR)-2. It received priority review and breakthrough therapy designation by the FDA. It was tested in a 52-week, randomized, double-blind, placebo-controlled trial of 663 adults (mean age 66 years, 54% male) who received either 150 milligrams or a placebo. While both the treatment and placebo group continued to have lung function decline by week 52, the treatment group had less lung function decline.

The treatment is currently uder study for cancer indications, including nonsmall cell lung cancer, colorectal cancer and ovarian cancer, according to researchers writing in the European Respiratory journal.