FDA Advisory Committee Recommends Approval of Drug to Treat Interstitial Lung Disease Caused by Systemic Sclerosis

According to a story from Healio, the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee recently voted 10-7 in favor of recommending the drug nintedanib as a treatment for interstitial lung disease (ILD) caused by systemic sclerosis. The drug is currently approved as a treatment for idiopathic pulmonary fibrosis (a form of ILD). The close vote was the result of concerns about the modest benefit of the drug; however, ILD in systemic sclerosis currently has no approved treatments.

About Systemic Sclerosis

Systemic sclerosis, which is also referred to as scleroderma, describes a group of autoimmune diseases that can cause system-wide effects in the most severe cases. The mechanism of this disease is believed to be an autoimmune response in which the immune system mistakenly attacks body tissue. Some factors that may contribute to triggering the autoimmune response include mutations of the HLA genes and exposure to certain materials, such as certain solvents, white spirits, ketones, and silica. Symptoms are broad ranging and systemic, including kidney failure, erectile dysfunction, fatigue, stroke, headaches, facial pain, congestive heart failure, skin abnormalities, high blood pressure, chest pain, indigestion, and many more. Treatments are varied and depend on the symptoms, but most patients take medications in an attempt to suppress the autoimmune response. In severe cases, life expectancy is around 11 years from onset. To learn more about systemic sclerosis, click here.

About Interstitial Lung Disease (ILD)

Interstitial lung disease describes any disease affecting the tissue around the lung’s air sacs. The disease is caused by an abnormal healing response which causes this tissue to thicken and scar. Systemic sclerosis is just one of many potential causes of ILD.

Study Findings

In a study of patients with systemic sclerosis associated ILD, nintedanib was able to reduce the rate of functional decline by an average of 44 percent as measured by forced vital capacity. While this improvement was significant, the drug failed to have any impact on secondary endpoints, such as improvements to other symptoms, overall mortality, and quality of life. 

While the drug earned the committee’s recommendation, dissenters on the panel voiced reservations about the treatment and recommended longer term studies to more thoroughly measure the impact of nintedanib.


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