BRIEF—FDA approves IV formulation of Akynzeo

Privately-held Swiss drugmaker Helsinn said today that the US Food and Drug Administration has approved the intravenous formulation of Akynzeo (fosnetupitant/palonosetron) as an alternative treatment option for patients experiencing chemotherapy-induced nausea and vomiting (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.

Helsinn plans to launch Akynzeo in IV formulation in the USA in May 2018.