FDA Completes Two ART Guidelines

The U.S. Food and Drug Administration (FDA) announced Tuesday, March 19, that it has completed work on two policies designed to describe guidelines for developing antiretroviral drugs for children and systemic drugs for HIV prevention (PrEP) )

The relevance of the development of these provisions is explained by the management of the fact that earlier in the country 29 drugs were approved for the treatment of HIV infection, and, according to the FDA Commissioner Scott Gottlieb, an integral part of the agency’s work is targeting vulnerable groups and risk groups.

“Although [the guidelines] are targeted at different populations affected by HIV, their ultimate goal is the same. We must continue to work to ensure the safety and efficacy of drugs used in the treatment and prevention of the virus in order to achieve [...] the main goal to eradicate this disease, ”Gottlieb emphasized.

The four-page manual on the treatment of HIV infection in children, the preparation of which was completed in May last year, outlines seven main considerations of the regulator addressed to the developers (for comparison: there were five of them in the draft). In particular, the FDA recommends that manufacturers in the development of antiretroviral therapy include teenagers in phase 3 clinical trials (efficacy) along with adults or conduct separate adolescent studies in parallel with adult CI.

“The FDA encourages developers to hold early discussions with WHO, nongovernmental organizations, the FDA and other associations regarding pediatric plans aimed at promoting the development of medicines for children (for example, regarding the choice of composition and dosage of the product),” the manual says.

The second document, which includes seven pages, was created in order to finalize the draft prepared in June last year. It contains recommendations for research drugs that are planned to be used in the future as pre-exposure prophylaxis for HIV infection (PrEP).

According to the regulator, these ART should include:

“(1) An [antiretroviral] oral preparation, [...] the indications of which will expand over time to pre-exposure prophylaxis of HIV infection (PrEP),

(2) an oral medication approved for the treatment of HIV infection that changes the dosage form and delivery methods to a long-acting product or other derivative tool (e.g., implantable device) for PrEP during the modification process or

(3) a new research systemic drug product designed to treat and / or prevent HIV infection. ”

Note that the guide includes a number of sections on clinical and non-clinical aspects, pharmacology, dosage selection and characteristics of long-acting systemic drugs.

The paper also provides considerations regarding the features of a Phase 3 clinical trial, including registration criteria, trial design, endpoint efficacy, and other study characteristics. Specialists call for special attention to the safety of pregnant women and adolescents.