FDA Approves Akynzeo For Chemo-Related Nausea/Vomiting
U.S. Food and Drug Administration has approved combination drug Akynzeo (netupitant and palonosetron) to treat nausea and vomiting among people undergoing chemotherapy, the agency said Friday in a press release.
The approved drug contains a new anti-nausea drug, netupitant, and palonosetron, which was approved to treat nausea and vomiting six years ago.
The effectiveness of drug was evaluated in two clinical studies involving 1,720 people. The trials proved that Akynzeo was more effective in preventing nausea and vomiting than palonosetron taken alone.
According to findings, 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.