Merck has announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for single-dose EMEND® (fosaprepitant dimeglumine) for injection, Merck’s substance P/neurokinin-1 (NK1) receptor antagonist, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy (MEC). EMEND has not been studied for the treatment of established nausea and vomiting.
The FDA approval is supported by data from a Phase 3 study that showed single-dose EMEND for injection, combined with other anti-vomiting medicines, provided greater protection from delayed nausea and vomiting following administration of moderately emetogenic chemotherapy versus an active control regimen. With this approval, EMEND for injection is the first intravenous single-dose NK1 receptor antagonist approved in the U.S. for both highly emetogenic chemotherapy (HEC) as well as MEC.
EMEND for injection is contraindicated in patients who are hypersensitive to any component of the product and in patients taking pimozide.
“Despite significant advances in supportive care, nausea and vomiting has remained a challenge for many cancer patients undergoing moderately emetogenic chemotherapy – and has historically required multi-day antiemetic therapy,” said Stuart Green, vice president, clinical research, Merck Research Laboratories. “Today’s approval of an expanded indication for EMEND for injection means that physicians now have a new single-dose intravenous option, combined with other anti-vomiting medicines, for the prevention of delayed nausea and vomiting in these patients.”