Nintedanib Gets Fast Track Designation for the Treatment of Scleroderma

According to a story from BioSpace, the U.S. Food and Drug Administration has given Fast Track designation for nintedanib, which is undergoing testing for the treatment of systemic sclerosis with underlying interstitial lung disease, more commonly known as scleroderma. The announcement was released by Boehringer Ingelheim Pharmaceuticals, Inc. on March 19th.
Scleroderma is a group of autoimmune diseases that can affect a variety of body systems, most commonly the skin. The muscles, blood vessels, and other internal organs may also be involved. While the cause is not fully understood, most theories center around an abnormal immune system response. Family history, exposure to silica, and some genetic factors may also be risk factors for scleroderma. The diseases may be localized, normally on the skin, or systemic, affecting many different parts of the body. The systemic form can have a major impact on lifespan, with an average expectancy of 11 years of survival from diagnosis. One of the most severe complications is interstitial lung disease, and others include problems with blood flow, digestive system abnormalities, muscle pain and weakness, and skin lesions. To learn more about scleroderma, click here.

The Fast Track designation from the FDA is a mechanism that allows for treatments that will fulfill a currently unmet medical need and that address serious medical conditions to proceed through the development phase at a more rapid pace. The news is an encouraging step for the company and the scleroderma patient community. To date there have been a very limited number of therapies that have been clinically tested for treating scleroderma and no approved treatments that are targeted for treating scleroderma with interstitial lung disease.

Nintedanib has already attained FDA approval for the treatment of another lung disease, idiopathic pulmonary fibrosis. In this condition, the drug helps slow the loss of lung function. The lung disease in scleroderma and pulmonary fibrosis are defined by the scarring of lung tissue, and the nature of this scarring appears to be similar, which led to the initial testing of nintedanib for scleroderma. The ability of the treatment to address many of the other problems that appear in scleroderma is still unclear.

Share this post

Follow us