FDA Accepts CINV NDA

The FDA has accepted for review the NDA from Helsinn Group and Eisai Inc. for the investigational oral fixed-dose combination capsule of netupitant 300 mg + palonosetron 0.50 mg (NEPA) for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) following both highly and moderately emetogenic chemotherapy.

 

The acceptance indicates that the FDA has found the submission to be sufficiently complete to review. Helsinn’s NDA is supported by data from pivotal studies evaluating the efficacy and safety of NEPA for the prevention of CINV following both highly and moderately emetogenic chemotherapy.

 

NEPA is an investigational single-day, fixed-dose combination of a selective NK1 receptor antagonist, netupitant, and a 5-HT3 receptor antagonist, palonosetron, designed to target two critical pathways thought to be associated with chemotherapy-induced nausea and vomiting (CINV).