FDA approves Emend (aprepitant) for paediatric patients to treat acute and delayed nausea and vomiting- Merck Inc.

Merck announced that the FDA has approved a supplemental New Drug Application (sNDA) for Emend (aprepitant) capsules, a substance P/neurokinin 1 (NK1) receptor antagonist. With this expanded indication, Emend capsules are now approved for use in combination with other antiemetic agents in patients 12 years of age and older and patients less than 12 years who weigh at least 30 kg (approximately 66 pounds) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin, as well as for the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

Aprepitant has not been studied for treatment of established nausea and vomiting. Chronic continuous administration of aprepitant is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use. With this approval, aprepitant is the first and only NK1 receptor antagonist to be approved for the prevention of acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV) in patients 12 to 17 years of age and patients less than 12 years who weigh at least 30 kg receiving HEC or MEC. The approval was supported by data from a pivotal Phase III study that showed adding aprepitant to a standard regimen for prevention of CINV in HEC or MEC regimens resulted in a reduction of emetic events.

Comment: The addition of the drug to a standard CINV regimen resulted in a reduction of emetic events; 51% of patients on aprepitant reached the primary endpoint of achieving complete response (no vomiting or retching and no use of rescue medication) 25–120 hours following the beginning of chemotherapy, compared to 26% of those on placebo.