Merck's anti-nausea drug for young chemotherapy recipients gains approval

Merck on Wednesday announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for EMEND (aprepitant) capsules, a substance P/neurokinin 1 receptor antagonist.

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 in patients 12 to 17 years of age and patients less than 12 years who weigh at least 65 pounds who are receiving highly or moderately emetogenic chemotherapy.

“The FDA approval of this expanded indication for EMEND is the result of our commitment to fully realizing the potential of our therapies to help as many patients as possible,” Stuart Green, vice president of clinical research at Merck Research Laboratories, said. “Historically, significant improvements in pediatric medicine have been slow due to many challenges such as clinical trial size. However, at Merck, these obstacles have invigorated our efforts to bring forward a new option for these patients.”

The approval was supported by data from a successful Phase 3 study showing the efficacy of EMEND.

Merck, a global health care leader, is known as MSD outside the United States and Canada. Through the company’s prescription medicines, vaccines, biologic therapies and animal health products, it works with customers and operates in more than 140 countries.