FDA panel backs InterMune's Esbriet

FDA's Pulmonary-Allergy Drugs Advisory Committee voted 9-3 to recommend approval of an NDA from InterMune Inc. (NASDAQ:ITMN) for Esbriet pirfenidone for idiopathic pulmonary fibrosis (IPF). While acknowledging FDA's concern that Esbriet had met the primary endpoint in only one of two Phase III trials, the panel judged that the totality of evidence supported the compound's risk-benefit profile. The committee was particularly swayed by pooled survival data from the two studies that consistently favored Esbriet, including a post-hoc analysis suggesting it significantly improved IPF-related mortality (See BioCentury Extra, Friday, March 05, 2010).

The panel also voted 7-5 that InterMune had provided substantial evidence of Esbriet's efficacy, and 9-3 in favor of the compound's safety. Esbriet is under Priority Review with a May 4 PDUFA date. Shionogi markets the oral p38 mitogen-activated protein kinase ( p38 MAPK; MAPK14) inhibitor as Pirespa for IPF in Japan. InterMune submitted an MAA to the European Medicines Agency (EMA) last week. ...