The recent approval by the U.S. Food and Drug Administration of Merck’s pediatric EMEND (aprepitant) capsules means that young cancer patients undergoing chemotherapy won’t have to suffer some of the side effects commonly associated with the disease.
“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,” An Phan, Merck’s director of global communications for oncology, told American Pharmacy News.
With this supplemental New Drug Application approval, Phan said that EMEND is “the first and only” neurokinin (NK1) receptor antagonist to be approved for use in combination with other antiemetic agents to prevent acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV).
These specific EMEND capsules, Phan said, are for use in patients 12 to 17 years of age and in patients under the age of 12 who weigh at least 66 pounds who are receiving highly or moderately emetogenic chemotherapy (HEC or MEC).
“The capsules are currently available as the dosing for this pediatric age group is identical to dosing for adults receiving HEC or MEC for their CINV,” Phan told American Pharmacy News.
Additionally, Phan said that the FDA-approved dosing schedule for this pediatric indication for EMEND capsules is 125 milligrams on Day One, followed by 80 milligrams on Day Two, and 80 milligrams on Day Three for patients 12 and older and patients under 12 weighing at least 66 pounds who can swallow oral capsules.
Phan said that oral EMEND was initially approved by the FDA in 2003. Since then, according to Phan, the drug has “received numerous new indications as a result of new clinical data during the past 12 years, most recently this indication for a pediatric subpopulation.”
This FDA approval follows similar pediatric-related news announced in February when Merck formalized an agreement with the Medicines Patent Pool (MPP) to license its pediatric formulations of raltegravir for use in treating HIV-1 infection in infants and children, ages 4 weeks to under 12 years, in developing countries.
By granting this free license, Merck allows any generic or brand name drug manufacturer to make low-cost pediatric versions of raltegravir and sell the drug in 92 low- and middle-income countries, according to the MPP, which is supported by the United Nations. The MPP also has said that Merck's medicine could become an alternative to the current initial HIV treatment for children.
Meanwhile, Merck says that raltegravir is being tested for possible use in newborns.
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