Posted by Michael Wonder on 21 Apr 2018
Helsinn Group announces the FDA approval of the IV formulation of Akynzeo (fosnetupitant/palonosetron) in the United States
20 April 2018 - Helsinn today announces that the U.S. FDA has approved the intravenous formulation of Akynzeo (NEPA, a fixed anti-emetic combination of fosnetupitant, 235 mg, and palonosetron, 0.25 mg) as an alternative treatment option for patients experiencing CINV.
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, including, but not limited to, highly emetogenic 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.
