Switzerland-based Helsinn Healthcare has obtained US Food and Drug Administration approval for its fixed combination capsule Akynzeo to treat patients with chemotherapy-induced nausea and vomiting (CINV).
Akynzeo is a combination of netupitant and and palonosetron, which targets two critical signaling pathways associated with CINV.
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Helsinn’s Group CEO Riccardo Braglia said: "Helsinn is delighted with the FDA approval of Akynzeo and we look forward to a successful launch in the US.
"We are proud of our long-standing partnership with Eisai and Akynzeo is the newest development in our combined efforts."
The approval was based on data from Phase II and Phase III clinical studies of Akynzeo in patients undergoing treatment with moderately and highly emetogenic chemotherapy regimens for various tumor types.
In June 2010, Eisai had signed a licensing agreement with Helsinn for Akynzeo. Based on the agreement, the US subsidiaries of both companies will market the product in the US.
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By GlobalDataEisai CEO Yuji Matsue said: "The approval of Akynzeo represents an important development in the prevention of acute and delayed nausea and vomiting for patients."
Both companies are also developing an injectable formulation to further maximise the value of Akynzeo.
Earlier this year, European Medicines Agency (EMA) started to review the submission of Helsinn’s marketing authorisation application for netupitant/palonosetron fixed combination for the prevention of acute and delayed CINV.
