Merck, commonly known as MSD, has received the US Food and Drug Administration (FDA) approval for its 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, can now be used for the prevention of delayed nausea and vomiting in adults who receive first and repeat courses of moderately emetogenic chemotherapy (MEC).
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The latest FDA approval is based on a randomised, parallel, double-blind and active comparator-controlled study, which revealed that single intravenous infusion of EMEND in combination with ondansetron and dexamethasone provide more protection against delayed nausea and vomiting than ondansetron and dexamethasone.
The main endpoint of the new indication is to achieve complete response, meaning no vomiting and no use of rescue therapy, in the delayed phase of chemotherapy-induced nausea and vomiting.
Compared to 68.5% complete response rate found with the control regimen, a 78.9% complete response rate was found with the EMEND regimen.
In the EMEND regimen versus control regimen exercise, fatigue, diarrhoea, neutropenia, asthenia, anaemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection and pain in extremity were found to be the most common adverse reactions.
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By GlobalDataAccording to Merck, the EMEND injection is contraindicated in patients who are hypersensitive to any elements of the product and in patients who take pimozide.
Merck Research Laboratories clinical research vice-president Stuart Green said: "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.
"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."
Last month, Merck receives FDA approval for ZEPATIER (elbasvir and grazoprevir) that treats Chronic Hepatitis C Virus Genotype 1 or 4 infection in adults.
