FDA approves sNDA for Emend (fosaprepitant dimeglumine) in combination with other antiemetic medicines for prevention of delayed nausea and vomiting- Merck Inc

Merck has announced that the FDA has approved a supplemental new drug application (sNDA) for single-dose Emend (fosaprepitant dimeglumine) for injection, 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 III 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 US 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.