BioCentury
ARTICLE | Company News

FDA accepts NDA for InterMune's pirfenidone

July 3, 2014 10:35 PM UTC

FDA accepted for review a resubmitted NDA from InterMune Inc. (NASDAQ:ITMN) for pirfenidone to treat idiopathic pulmonary fibrosis (IPF). The agency designated the NDA a Class 2 resubmission, with a Nov. 23 PDUFA date, InterMune said. In 2010, FDA issued a complete response letter for the compound asking for an additional clinical trial. The NDA resubmission includes data from the new Phase III ASCEND trial, as well as pooled data combining ASCEND with two earlier Phase III trials. Pirfenidone is a small molecule inhibitor of proinflammatory cytokines and pro-fibrotic cytokines.

On Wednesday, FDA accepted and granted Priority Review to an NDA from Boehringer Ingelheim GmbH (Ingelheim, Germany) for nintedanib ( BIBF 1120) to treat IPF. Boehringer declined to disclose the PDUFA date, but a six-month review could place FDA action on the compound at around the same time as pirfenidone. Phase III data presented in May at the American Thoracic Society meeting suggested that pirfenidone may have the upper hand against nintedanib, a small molecule inhibitor of multiple pro-angiogenic kinases, in IPF (see BioCentury, May 26). ...