Swissmedic approves Akynzeo® (netupitant/palonosetron) for use in the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Switzerland
- First Fixed Combination Targeting Two Key Pathways Involved in CINV -
Wednesday, 16 December 2015, ↓ directly to download
Lugano and Villars-sur-Glâne, Switzerland, December 15th, 2015 – Helsinn, the Swiss Group focused on building quality in cancer care, and Vifor Pharma, announced today 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 6th November 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 Group Chief Executive Officer, commented: “Helsinn is delighted to confirm approval of Akynzeo® for use in our home market of Switzerland, following approvals by both European and U.S. 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.
About the Helsinn Group
Helsinn is a family run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products. Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, the U.S. and a representative office in China. Helsinn's business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in the therapeutic area of cancer care.
Helsinn Group in-licenses early-to-late stage new chemical entities, completing their development by performing preclinical and clinical studies and associated manufacturing activities. Helsinn then prepares necessary regulatory filings in order to achieve marketing approvals worldwide. Helsinn's products are out-licensed to its global network of marketing and commercial partners that have been selected for their local market knowledge and high ethical standards. Helsinn supports these partners by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice.
In March 2013, Helsinn established a new commercial organization within its subsidiary, Helsinn Therapeutics (U.S.), Inc., in order to conduct direct sales and marketing activities within the U.S. market. Helsinn’s products are manufactured according to the highest quality, safety, and environmental standards at Helsinn's GMP facilities in Switzerland and Ireland from where they are then supplied worldwide to customers. Further information on Helsinn Group is available at www.helsinn.com.
About Vifor Pharma
Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world.
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