FDA Approves AKYNZEO® (netupitant/palonosetron) for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV)

Lugano, Switzerland and Woodcliff Lake, N.J., October 13, 2014 – Helsinn Group and Eisai Inc. announced today that the Food and Drug Administration (FDA) approved AKYNZEO® for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO is the first approved fixed combination oral agent that targets two critical signaling pathways associated with CINV by combining netupitant, an NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist, in a single capsule for the prevention of CINV.

"Patients receiving chemotherapy face a significant burden due to CINV. AKYNZEO may help alleviate part of that burden of chemotherapy by better managing nausea and vomiting up to five days following chemotherapy," said Paul J. Hesketh, M.D., AKYNZEO pivotal study lead author and chair, Lahey Health Cancer Institute and director of Thoracic Oncology, Lahey Hospital & Medical Center. “The results from the pivotal trials show that AKYNZEO provides superior prevention against nausea and vomiting compared with oral palonosetron. As a result, physicians may be able to help patients manage CINV with a treatment that works both at the time of chemotherapy administration, and up to five days following treatment."

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