Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, announces that the intravenous formulation of AKYNZEO® (a fixed antiemetic combination of fosnetupitant) for injection has been launched in the United States by its U.S. subsidiary, Helsinn Therapeutics (U.S.).
The FDA, has approved AKYNZEO® IV in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. AKYNZEO® for injection has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.
Oral AKYNZEO® was previously approved by the FDA as a fixed combination oral agent in 2014 for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy. AKYNZEO® is an oral fixed combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.
The bioequivalence of fosnetupitant and netupitant was demonstrated in a Phase 1 study and the safety of IV AKYNZEO® was established through a repeated dose safety study in cancer patients to potentially uncover adverse drug reactions that may appear during subsequent clinical practice.
The prevention of CINV has significantly evolved over the past several decades. Currently the combination treatment of antiemetic medicines with different mechanisms of actions is recommended by the main international antiemetic guidelines for the prevention of CINV in most settings.
Giorgio Calderari, Helsinn Group General Manager, commented: “This is an important moment for Helsinn, as it allows us to bring an additional option to patients experiencing CINV in highly emetogenic chemotherapy treatment.”