Boehringer files for new rare disease use for nintedanib in EU, US
Pharmaphorum Media Limited | March 19, 2019
Boehringer Ingelheim has filed for a new use for its lung drug nintedanib in the US and Europe, bidding to add the rare disease systemic sclerosis to the existing indication for idiopathic pulmonary fibrosis (IPF). The German pharma said it had filed dossiers with the FDA and the European Medicines Agency (EMA) for nintedanib, for interstitial lung disease associated with systemic sclerosis (SSc-ILD). Nintedanib is an anti-fibrotic medicine approved in more than 70 countries for the treatment of adults with IPF. Systemic sclerosis, also known as scleroderma, is a rare, immune-mediated rheumatic disease characterized by thickening and scarring (fibrosis) of connective tissue throughout the body, which can be debilitating and possibly life-threatening. The charity Scleroderma & Raynaud’s UK estimates that around 2.5 million people have scleroderma worldwide.