Eisai, Helsinn Group announce FDA approval of AKYNZEO for prevention of CINV

First New Fixed Combination Targeting Two Critical Pathways Involved in CINV

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."

The approval of AKYNZEO was based on the submission of Phase 2 and Phase 3 trials with AKYNZEO in patients undergoing treatment with moderately and highly emetogenic chemotherapy regimens for a variety of tumor types. The most common adverse reactions reported with AKYNZEO were headache, asthenia, fatigue, dyspepsia, constipation and erythema.

CINV is one of the most common side effects of chemotherapy. Its management has been refined over the past several decades, but despite the existence of effective treatments and clear antiemetic guidelines, many patients still suffer from CINV, particularly during the delayed phase after chemotherapy. Studies show that patients often receive antiemetic drug regimens that are inconsistent with CINV treatment guidelines, which call for multiple-pathway targeted antiemetic prophylaxis. AKYNZEO provides cancer care teams with two antiemetics in a single oral fixed combination capsule. A combination of an NK₁ receptor antagonist, a 5-HT₃ receptor antagonist and dexamethasone meets guideline recommendations for optimal antiemetic therapy following highly emetogenic chemotherapy.

"Helsinn is delighted with the FDA approval of AKYNZEO and we look forward to a successful launch in the United States. We are proud of our long-standing partnership with Eisai and AKYNZEO is the newest development in our combined efforts," said Riccardo Braglia, Helsinn's Group Chief Executive Officer. "This approval offers patients access to a new treatment option for CINV prevention that is effective in preventing both nausea and vomiting, particularly in the delayed phase, following emetogenic chemotherapy regimens."

"The approval of AKYNZEO represents an important development in the prevention of acute and delayed nausea and vomiting for patients," said Yuji Matsue, Chairman and Chief Executive Officer, Eisai Inc. "We are proud to achieve this milestone with AKYNZEO as we work to further our human health care mission to provide patients going through what we know can be emotionally- and physically-demanding cancer treatment with an additional option for CINV prevention."