FDA approves Eisai's Akynzeo for CINV

The US Food and Drug Administration has approved Japanese pharma major Eisai’s (TYO: 4523) Akynzeo (netupitant and palonosetron) to treat chemotherapy-induced nausea and vomiting (CINV). The drug will be distributed and marketed in the USA by Eisai Inc, under license from privately-held Swiss drugmaker Helsinn Healthcare.

Akynzeo is a fixed combination capsule comprised of two drugs. Oral palonosetron, approved in 2008 under the trade name Aloxi, prevents nausea and vomiting during the acute phase (within the first 24 hours) after the start of cancer chemotherapy. Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase (from 25 to 120 hours) after the start of cancer chemotherapy.

“Supportive care products, such as Akynzeo, help ease the nausea and vomiting patients may experience as a side effect of cancer chemotherapy,” said Julie Beitz, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.