US FDA approved Ofev for treatment of interstitial lung disease associated with systemic sclerosis

Boehringer Ingelheim Pharmaceuticals’ Ofev (nintedanib) is approved in the United States for the treatment of interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. Ofev is the first drug indicated for the treatment of the rare lung disease.

Scleroderma is a condition where the internal lining of the lung gets thickened. In interstitial lung disease or ILD, the interstitium gets thickened. ILD is the most common reason for death in patients who have scleroderma.

The efficacy of Ofev (nintedanib) was studied in 576 patients ages 20-79 with the disease. The patients were treated for 52 weeks, forced vital capacity (FVC) is the primary endpoint. The patients administered with Ofev has more lung capacity than patients administered with placebo.

The prevalence estimates of scleroderma in the United States is 100,000.