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খবর

The Helsen Akynzeo Intravenous Preparation Has Been Approved By The European Union, And The Capsule Has Been Launched In China!

[May 07, 2020]

Swiss pharmaceutical group Helson Group recently announced that the European Commission (EC) has approved Akynzeo (fosnetupitant 235mg / palonosetron 0.25mg) intravenous preparation (IV) as an alternative treatment to prevent chemotherapy-induced nausea and vomiting (CINV ).


In Europe, Akynzeo oral hard capsules (netupitant 300mg / palonosetron 0.5mg) were approved in 2015 for the prevention of acute or delayed CINV in patients receiving highly and moderately emetic chemotherapy drugs.

akynzeo

Helsinn submitted a marketing authorization application (MAA) for Akynzeo IV in November 2018 as an extension of Akynzeo hard capsules. In December 2019, the European Medicines Agency (EMA) Committee for Human Pharmaceutical Products (CHMP) issued a positive review opinion in support of approval. The approval of Akynzeo IV preparation will provide an alternative route of administration for European patients and healthcare providers.


It is worth mentioning that Akynzeo is the only fixed-dose antiemetic combination product that can simultaneously target two different CINV pathways through single-dose therapy. Akynzeo intravenous preparation (IV) is a new fixed-dose combination preparation made of fosnetupitant and palonosetron; among them, fosnetupitant is a netupitant prodrug that increases water solubility and makes injections possible, which can be converted to netupitant in the body , The latter is a highly selective NK1 receptor antagonist; palonosetron (palonosetron) is a 5-HT3 receptor antagonist.


In China, Akynzeo capsules were approved on August 2, 2019 for adult patients: prevention of acute nausea and vomiting caused by highly emetic chemotherapy and delayed nausea and vomiting, prevention of acute nausea and vomiting caused by moderate emetic chemotherapy And delayed nausea and vomiting. Mengdi Chinese Pharmaceutical Company owns the exclusive marketing and sales rights of Akynzeo® Capsules in China,


Although many drugs are available, CINV control in many cancer patients undergoing chemotherapy is still not ideal. Akynzeo capsules and Akynzeo injection preparations can simultaneously block two CINV signaling pathways in a single administration, which can help patients and their families improve their quality of life.