FDA approves Ofev (nintedanib) for treatment of Idiopathic Pulmonary Fibrosis-Boehringer

The FDA has on 15 October 2014 approved Ofev (nintedanib) from Boehringer for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The FDA granted Ofev fast track, priority review, orphan product, and breakthrough designations.

Ofev (known as Vargetef ouside the USA) is a kinase inhibitor that blocks multiple pathways that may be involved in the scarring of lung tissue. Its safety and effectiveness were established in three clinical trials of 1,231 patients with IPF. The decline in forced vital capacity – the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible – was significantly reduced in patients receiving Ofev compared to patients receiving placebo.