EU approves Akynzeo IV formulation for treating nausea.- Helsinn

Helsinn announced that the European Commission (EC) has approved the intravenous formulation of Akynzeo (fosnetupitant, 235mg, and palonosetron, 0.25mg) as an alternative treatment option for preventing CINV. The European approval follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), in December 2019. Helsinn submitted its MAA to the EMA for Akynzeo IV in November 2018, as a line extension of oral Akynzeo. Akynzeo hard capsules was previously approved by the European Commission as a fixed dose combination in 2015 for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin?based cancer chemotherapy and moderately emetogenic cancer chemotherapy.Comment: Akynzeo (oral and IV) is indicated in the EU for adults for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy.