NEPA regulatory update

EMA accepted for review an MAA from Helsinn for NEPA to prevent acute and delayed chemotherapy-induced nausea and vomiting (CINV). The product is also under review for the indication in the U.S., where it has a Sept. 26 PDUFA date. 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. ...