The FDA has issued two final guidance documents that the agency hopes will help drug sponsors develop more effective HIV prevention medicines and HIV treatments for children.
“Although aimed at different populations affected by HIV, the end goal of these guidances is the same,” Commissioner Scott Gottlieb said — ensuring the safety and effectiveness of HIV drugs and “[setting] as a goal the eradication of this disease.”
The first guidance document, on pediatric HIV drugs, finalizes recommendations first outlined in a draft issued last year.
The agency urges drug sponsors to include adolescents—defined as children between 12 and 17 years old—in Phase III adult trials. Sponsors should begin pediatric formulas as soon as Phase II trials have helped to zero in on the adult dose. They should enroll newborns once they have reviewed pharmacokinetic data and established doses for older children and should base enrollment and dosing on weight rather than age, the agency says. Sponsors can use relative bioavailability studies in adults to obtain new pediatric formulas if there are established pediatric dosing regimens for previously approved formulas.