FDA approves new indication for Merck's Emend

The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for single-dose Emend (fosaprepitant dimeglumine) for injection.

Emend, Merck & Co’s (NYSE: MRK) substance P/neurokinin-1 (NK1) receptor antagonist, in combination with other antiemetic medicines, is now cleared 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 USA for both highly emetogenic chemotherapy (HEC) as well as MEC.