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Helsinn receives European approval of its IV formulation of Akynzeo

23 Mar 2020

The new formulation offers patients in Europe an alternative route of administration of the only fixed antiemetic combination targeting two distinct CINV pathways in a single dose.

The European Commission (EC) has approved Helsinn's intravenous (IV) formulation of AKYNZEO as an alternative treatment option for preventing chemotherapy-induced nausea and vomiting (CINV).

Akynzeo hard capsules was previously approved by the EC as a fixed-dose combination in 2015 for the prevention of acute and delayed CINV.

The intravenous formulation of Akynzeo (NEPA, a fixed antiemetic combination of fosnetupitant and palonosetron) offers patients in Europe and healthcare providers an alternative route of administration of the only fixed antiemetic combination targeting two distinct CINV pathways in a single dose.

The European approval follows a positive opinion by the European Medicines Agency (EMA) 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.

Riccardo Braglia, Helsinn Group Vice Chairman and CEO, said he anticipates launching Akynzeo IV in Europe starting from the second quarter this year and hopes to expand the reach of this treatment across the globe.

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