FDA Approves Pediatric Indication for Emend (aprepitant) Capsules in Combination with Other Antiemetic Agents

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (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). Emend has not been studied for treatment of established nausea and vomiting. Chronic continuous administration of Emend is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use.
With this approval, Emend 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 3 study that showed adding Emend to a standard regimen for prevention of CINV in HEC or MEC regimens resulted in a reduction of emetic events.
Emend is contraindicated in patients with any known sensitivity to any component of this drug. Emend is also contraindicated for patients taking pimozide.
There is no commercially available dosage formulation of Emend appropriate for patients less than 12 years of age and weighing less than 30 kg. Therefore, Emend is indicated for the prevention of nausea and vomiting associated with HEC or MEC in patients 12 years of age and older and patients less than 12 years of age who weigh at least 30 kg.

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Source: Drugs.com New Drugs, Septemeber 2015 (http://www.drugs.com/newdrugs/fda-approves-pediatric-indication-emend-aprepitant-capsules-combination-other-antiemetic-agents-4255.html?utm_source=ddc&utm_medium=email&utm_campaign=Today%27s+news+summary+-+September+2%2C+2015&utm_content=FDA+Approves+Pediatric+Indication+for+Emend+%28aprepitant%29+Capsules+in+Combination+with+Other+Antiemetic+Agents)