Merck announced that the Food and drug Administration (FDA) has approved Emend (fosaprepitant dimeglumine) for Injection, for use in combination with other antiemetic agents, to prevent delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy (MEC). This makes Emend for Injection the first intravenous (IV) single-dose NK1 receptor antagonist approved for both moderately and highly emetogenic chemotherapy.
The approval was based on data from a Phase 3 randomized, parallel, double-blind, active comparator-controlled study. This showed single-dose Emend for Injection, combined with ondansetron and dexamethasone, provided greater protection from delayed nausea and vomiting following administration of moderately emetogenic chemotherapy vs. an active control regimen (ondansetron and dexamethasone). A 78.9% complete response rate was seen with the Emend regimen vs. 68.5% with the control regimen (P<0.001).
Emend for Injection is already approved for use in combination with other antiemetic agents to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of moderately to highly emetogenic cancer chemotherapy, including high-dose cisplatin. It is a substance P/neurokinin-1 (NK1) receptor antagonist
Emend for Injection is available as 115mg/vial or 150mg/vial strengths.
For more information call (877) 888-4231 or visit Emend.com.