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FDA APPROVES MERCK'S EMEND
Merck has announced that the FDA has approved Emend (aprepitant) for use with other anti-emetic medicines for the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, which are likely to cause nausea and vomiting. Emend, in combination with other anti-emetics, is also approved for the prevention of nausea and vomiting caused by initial and repeat courses of highly emetogenic chemotherapy treatments, which are highly likely to cause nausea and vomiting, including high-dose cisplatin.
The FDA approval for EMEND is based on the findings of a study published in April 2005 in the Journal of Clinical Oncology that enrolled 866 breast cancer patients, of whom 99.5 percent were women. The study compared a regimen including Emend (Emend in combination with ondansetron, a 5-HT3 receptor antagonist, and dexamethasone, a corticosteroid, on Day 1 followed by EMEND on Days 2 and 3) and a standard regimen (ondansetron and dexamethasone on Day 1 followed by ondansetron on Days 2 and 3).
KEYWORDS Drug Pipeline Alert
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