NEPA regulatory update

FDA accepted for review an NDA from Helsinn for NEPA to prevent acute and delayed chemotherapy-induced nausea and vomiting (CINV). The PDUFA date is Sept. 26. The product is a fixed-dose combination of 300 mg netupitant, a neurokinin 1 (NK1) substance P receptor antagonist, and 0.5 mg palonosetron, a selective serotonin (5-HT3) receptor antagonist. Palonosetron is marketed to prevent CINV under the names Aloxi, Paloxi and Onicit in more than 60 countries worldwide. If approved, Eisai Co. Ltd. (Tokyo:4523, Tokyo, Japan) and Helsinn will co-promote NEPA in the U.S. Eisai gained North American rights to the product through its 2008 acquisition of MGI Pharma Inc., which had North American rights to distribute Aloxi from Helsinn (see BioCentury, Dec. 17, 2007 & Feb. 8, 2008). ...