Orphan drug designation granted to nintedanib for treatment of systemic sclerosis

The European Commission (EC) and US Food and Drug Administration (FDA) have granted Orphan Drug Designation to nintedanib for the treatment of systemic sclerosis (SSc), including the associated interstitial lung disease (SSc-ILD). Systemic sclerosis, commonly referred to as “scleroderma,” is a disfiguring, disabling and potentially fatal rare disease that can cause scarring of the skin, lungs (SSc-ILD) and other organs. Worldwide, an estimated two million people have systemic sclerosis and up to 90% may develop some degree of lung scarring. SSc-ILD indicates a poor prognosis and accounts for 35% of all disease-related deaths. “Scleroderma and associated interstitial lung disease have