US regulators have approved a single-dose version of Merck & Co’s chemotherapy-associated nausea and vomiting drug Emend.
The jab’s use has been cleared, in combination with other anti-emetics, for the prevention of delayed nausea and vomiting in adults taking moderately emetogenic chemotherapy (MEC).
The decision makes Emend (fosaprepitant dimeglumine) the first intravenous single-dose NK1 receptor antagonist approved in the US for both highly emetogenic chemotherapy (HEC) as well as MEC.
Clearance was issued on the back of data from a Phase III study in which a 78.9 percent complete response rate was observed with the Emend regimen compared to 68.5 percent with the active control regime.
“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, who heads clinical research at Merck Research Laboratories.
The approval of an expanded indication “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.”
The pill form of Emend was approved back in 2003.