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MGI Aloxi approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

MGI Pharma's Aloxi (palonosetron) clears FDA July 25 for prevention of "acute nausea and vomiting associated with initial and repeat courses of moderately to highly emetogenic chemotherapy" and "prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy," making it the first 5-HT3 antagonist approved for delayed chemotherapy-induced nausea and vomiting. Marketing efforts will focus on Aloxi's differentiated labeling, superior clinical results and potential pharmacoeconomic benefits. MGI has pointed to the agent's greater affinity for 5-HT3 receptors and longer half-life as key distinguishing factors from GSK's Zofran, Aventis' Anzemet and Roche's Kytril (1Pharmaceutical Approvals Monthly June 1, 2003, p. 7). MGI also notes the potential for use with Merck's substance P antagonist Emend (aprepitant). Aloxi will be priced above the other 5-HT3 agents...
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