FDA Approves Merck’s Anti-Nausea and Vomiting Drug for Children
The FDA has approved Merck’s anti-nausea and vomiting drug Emend for children undergoing chemotherapy, making the drug the first and only NK1 receptor antagonist for this indication.
Emend (aprepitant) is indicated to prevent acute and delayed phases of chemotherapy-induced nausea and vomiting in patients 12 to 17 years of age or younger than 12 years who weigh at least 66 pounds receiving highly or moderately emetogenic chemotherapy.
The drug — a selective high-affinity antagonist of human substance P/neurokinin receptors — was approved for adults in 2003. The expanded indication was based in part on data from a pivotal Phase 3 study showing that the addition of Emend to a standard CINV regimen resulted in fewer emetic events.
Roughly 35 percent of patients on Emend experienced no vomiting or retching and required no use of rescue medication for up to 120 hours following initiation of chemotherapy, compared with 13 percent on placebo, according to Merck. — Jonathon Shacat