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The guidance provides nonclinical and clinical recommendations to sponsors for the development of products for the prevention of HIV-1 infection.
FDA published guidance on March 19, 2019 that provided nonclinical and clinical recommendations to sponsors for the development of systemic drug products for the prevention of sexually acquired human immunodeficiency virus-1 (HIV-1) infection.
The guidance specifically addresses long-acting systemic drug products, including small molecules and monoclonal antibodies. The guidance discusses the overall development program and clinical trial designs.
FDA states in the guidance that pre-exposure prophylaxis (PrEP) for HIV-1 products can include “an oral drug product approved for the treatment of HIV-1 infection that is subsequently developed as oral PrEP; an oral drug product approved for the treatment of HIV-1 infection that is reformulated as a long-acting drug product or other delivery system (e.g., injectable, implantable device) for PrEP; or a new investigational systemic drug product that is developed for treatment and/or prevention of HIV-1 infection.”
“FDA recognizes the challenges in evaluating systemic drug products for the prevention of sexually acquired HIV-1 infection. FDA continues to evaluate possible approaches for the development of new therapies for HIV prevention and will update this guidance if new information becomes available. FDA encourages the sponsor considering development of systemic drug products for the prevention of HIV-1 infection to communicate with FDA through the preinvestigational new drug application consultation program,” the agency states in the guidance.