FDA approves pediatric use of Merck’s Emend
The agency says the drug can be used, in combination with other antiemetics, in patients 12 years and older—as well as those younger than 12 who weigh at least 66 pounds—to prevent acute and delayed chemotherapy-induced nausea and vomiting (CINV).
With the approval, Emend (aprepitant) becomes the first and only NK1 receptor antagonist cleared for that indication and patient group.
The clearance was supported by results from a phase III study showing that the addition of the drug to a standard CINV regimen resulted in a reduction of emetic events. Some 51% of patients on Emend reached the primary endpoint of achieving complete response—no vomiting or retching, and no use of rescue medication—between 25 and 120 hours after the beginning of chemotherapy, compared to 26% of those on placebo.