New FDA guidance for developing PrEP drugs

Simon Collins, HIV i-Base

The US Food and Drug Administration (FDA) has produced draft guidance for developing new treatment as HIV PrEP.

The guidance provides general nonclinical and clinical recommendations specific to the development of systemic drugs to prevent HIV. It has a focus on long acting products. 

It addresses the FDA’s current thinking regarding the overall development programme and clinical trial designs, and include three options. 

  1. Oral HIV drugs that are subsequently developed as oral PrEP.
  2. Oral HIV drugs that are reformulated as a long-acting drug product or other delivery system for PrEP.
  3. New investigational drugs.

The deadline for comments is 13 August 2018.


HIV-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis. (PDF)

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