FDA accelerates approval for Esbriet, Ofev

FDA on Wednesday approved two drugs for idiopathic pulmonary fibrosis (IPF): Esbriet pirfenidone from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) and Ofev nintedanib from Boehringer Ingelheim GmbH (Ingelheim, Germany).

Both products had breakthrough and Fast Track designations and were approved ahead of their PDUFA dates: Nov. 23 for Esbriet and Jan. 2, 2015, for Ofev. The PDUFA date for Boehringer's drug, which it has previously called Vargatef, had not been disclosed previously. ...