The FDA has approved Merck's supplemental new drug application for single-dose fosaprepitant dimeglumine for injection.
The FDA has approved Merck’s supplemental new drug application for single-dose fosaprepitant dimeglumine (Emend) for injection.
Patients undergoing moderately emetogenic chemotherapy may use Emend, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting.
Emend should not be used for treating established nausea and vomiting, since that indication has not been studied.
“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 of clinical research for Merck Research Laboratories, in a press release. “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.”
The FDA’s approval is based on data from a phase 3 study that showed Emend could provide a greater delay in nausea and vomiting than other medicines.
Emend is now the first intravenous single-dose NK1 receptor antagonist approved in the United States for moderately emetogenic chemotherapy.
The most common adverse effects associated with Emend include fatigue, diarrhea, neutropenia, and asthenia.