USA – FDA Finalizes Two Guidances on HIV Drug Development

The US Food and Drug Administration (FDA) on Tuesday finalized two guidance documents to support the development of antiretroviral drug products for the treatment of human immunodeficiency virus (HIV) infection in pediatric patients and to aid the development of systemic drugs for the prevention of HIV-1 infection.

The guidance from FDA comes as the agency has approved 29 drugs to treat HIV infection. FDA Commissioner Scott Gottlieb said in a statement that the guidance is part of the agency’s work to address vulnerable or at-risk populations.

“Although aimed at different populations affected by HIV, the end goal of these guidances is the same. We must continue the work of ensuring the safety and effectiveness of drugs used in HIV treatment and prevention so that we can attain the healthier future and set as a goal the eradication of this disease, » Gottlieb said.

The four-page guidance on pediatric HIV treatments, finalizing the draft from last May, outlines seven major considerations for sponsors (up from five in the draft). FDA advises sponsors developing antiretroviral (ARV) drugs to include adolescents in the initial phase 3 (efficacy) clinical trials along with adults, or to conduct a separate adolescent study in parallel with the adult phase 3 clinical trials…