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FDA Approves Boehringer's Ofev To Treat Rare Lung Condition


The U.S. Food and Drug Administration approved Ofev (nintedanib) capsules, made by Boehringer Ingelheim Pharmaceuticals Inc., to treat a rare type of lung disease.

The drug slows the rate of decline in pulmonary function in adults with systemic sclerosis or scleroderma-associated interstitial lung disease Ssc-ILD. FDA noted that this is the first approved treatment for this rare lung condition.

Scleroderma causes tissue throughout the body, including the lungs and other organs, to thicken and scar. SSc-ILD is a progressive lung disease in which lung function declines over time, and is life-threatening.

The approval was based on the results of a randomized, double-blind, placebo-controlled trial of 576 patients ages 20-79 with the disease. Patients received treatment for 52 weeks, with some patients treated up to 100 weeks. The patients who took Ofev had less lung function decline compared to those on placebo.

In 2014, Ofev was originally approved to treat adult patients with idiopathic pulmonary fibrosis or IPF, another interstitial lung condition.

Nikolay Nikolov, associate director for Rheumatology of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research, said, "Patients suffering from scleroderma need effective therapies..... Nintedanib is now a treatment option to slow the rate of decline in pulmonary function in patients who have interstitial lung disease from scleroderma."

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