Helsinn, the Swiss Group focused on building quality in cancer care, and Vifor Pharma, a company of the Galenica Group, announced that Swissmedic, the Swiss agency for therapeutic products, has approved Akynzeo (netupitant/palonosetron) for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adults.
The approval was granted on November 6, 2015. Akynzeo is a new oral fixed combination of netupitant, a highly-selective NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist, for the prevention of acute and delayed nausea and vomiting associated with highly or moderately emetogenic cancer chemotherapy.
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 international antiemetic guideline recommendations, which call for multiple-pathway targeted antiemetic prophylaxis.
Akynzeo provides cancer care professionals with a single oral fixed combination of two antiemetics in one capsule (an NK1 receptor antagonist with a 5-HT3 receptor antagonist). This combination, together with dexamethasone, meets guideline recommendations for optimal antiemetic therapy following highly emetogenic chemotherapy.
Akynzeo was approved by the US Food and Drug Administration (FDA) in October 2014 and by the European Commission in May 2015.
Riccardo Braglia, Helsinn vice chairman and Group CEO, commented, “Helsinn is delighted to confirm approval of Akynzeo for use in our home market of Switzerland, following approvals by both European and US regulators. In addition to the National Comprehensive Cancer Network (NCCN) antiemetic guidelines where Akynzeo is recommended both in HEC and MEC, Akynzeo was also recently validated by ASCO as an additional therapy that will facilitate the application of standard of care for patients receiving highly emetogenic chemotherapy regimens, by preventing nausea and vomiting in both the acute and delayed phases following chemotherapy treatment. Approval for use also in Switzerland will allow us to accelerate our mission to provide patients who are undergoing cancer treatment, with an improved treatment option for CINV.”
“For Vifor Pharma, the Helsinn Group has been an excellent partner for many years. We are happy to complement our portfolio with the distribution of Akynzeo, another innovative product which will enable us to provide patients and doctors with better solutions,” added Josef Troxler, general manager, Vifor Pharma Switzerland and Austria.