FDA: Akynzeo approved for chemo-related nausea / vomiting
(HealthDay)—The combination drug Akynzeo (netupitant and palonosetron) has been approved by the U.S. Food and Drug Administration to treat nausea and vomiting among people undergoing chemotherapy, the agency said Friday in a news release.
Akynzeo contains a new anti-nausea drug, netupitant, and palonosetron, which was approved to treat nausea and vomiting in 2008.
The combination drug's effectiveness was evaluated in two clinical studies involving 1,720 people. The trials established that Akynzeo was more effective in preventing nausea and vomiting than palonosetron taken alone, the FDA said. The most frequent side effects of the combination drug included headache, weakness, fatigue, dyspepsia, and constipation.
"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, M.D., director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, in an agency news release.
Akynzeo is marketed and distributed by Eisai Inc. of Woodcliff Lake, N.J., under license from Switzerland-based Helsinn Healthcare.