Drugs

HIV Drug Product Draft Guidance

FDA has published a draft guidance, Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis, to give sponsors clinical and non-clinical recommendations specific to developing systemic drug products, with a focus on long-acting systemic drug products regulated within CDER for preventing sexually acquired HIV-1 infection. The document specifically addresses the agency’s current thinking about the overall development program and clinical trial designs to support development of systemic drug products for prevention of HIV-1 infection.

According to the guidance, investigational drug products for further development as pre-exposure prophylaxis (PrEP) can include (1) an oral drug product approved for treating HIV-1 that is subsequently reformulated as oral PrEP; (2) an oral drug product approved for treating HIV-1 infection that is reformulated as a long-acting drug product or other delivery system for pre-exposure prophylaxis; or (3) a new investigational drug product.

The guidance does not address development of vaginal microbicide drug products. It also does not contain discussion of the general issues of statistical analysis or clinical trial design.

“Sponsors considering development of drug products for the prevention of HIV-1 infection are encouraged to communicate with FDA through the pre-investigational new drug application program,” FDA says.

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