FDA Approves Akynzeo for Nausea, Vomiting from Chemotherapy Treatments
Marc Maligalig | | Oct 13, 2014 08:00 PM EDT |
(Photo : REUTERS) The FDA headquarters at Silver Spring, Maryland.
The United States Food and Drug Administration announced Friday in a press release that it has given the green light for the combination drug Akynzeo to treat nausea and vomiting in patients undergoing chemotherapy.
Akynzeo is comprised of palonosetron, which was approved to treat vomiting and nausea in 2008, and netupitant, a new anti-nausea drug.
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The effectiveness of the combination of drugs was assessed in two clinical studies with 1,720 people testing the medication. The FDA said the trials demonstrated that Akynzeo was more effective in averting nausea and vomiting that taking palonosetron alone.
The drug, however, is not without its side effects, as constipation, dyspepsia, fatigue, headaches and weaknesses were recorded in the clinical tests.
"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 distributed and marketed by Eisai Inc., based in Woodcliff Lake, N.J., under license from Helsinn Healthcare, whose headquarters are located in Switzerland.
Meanwhile, the FDA has approved another combination drug that can eliminate a chronic disease, along with funds in the patient's bank account.
Harvoni, a pill to be taken every day to treat hepatitis C that is easier to take but is pricier compared to the existing treatments, was given the go signal by the agency on Friday.
Manufactured by California-based Gilead Sciences, the combination pill has an 99 percent cure rate in trial patients after they took the drug for two to three months.
While the combination is effective, the full price of a 12-week course of treatment is $94,500, which equates to $1,125 per pill.
The pill combines ledipasvir and sofosbuvir, which is a previously approved hepa C drug marketed by Gilead under the brand name Sovaldi.
TagsFDA, drug, Akynzeo, Chemotherapy, Nausea, Vomiting, palonosetron, netupitant, Eisai Inc.
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