Posted by Michael Wonder on 24 Mar 2020
Helsinn announces European approval of the IV formulation of Akynzeo (fosnetupitant with palonosetron)
23 March 2020 - Helsinn today announces that the European Commission has approved the intravenous formulation of Akynzeo, (a fixed anti-emetic combination of fosnetupitant, 235 mg, and palonosetron, 0.25 mg) as an alternative treatment option for preventing CINV.
The European approval follows a positive opinion by the EMA Committee for Medicinal Products for Human Use in December 2019.
Helsinn submitted its MAA to the EMA for Akynzeo IV in November 2018, as a line extension of oral Akynzeo.
