Drugs

PEPFAR Antiretroviral Drug Guidance

David McFarland

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FDA has published a draft guidance, Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of HIV-1 Under PEPFAR, with recommendations for applications for these products. Specifically, the document addresses versions of previously approved single-entity (SE) and fixed-combination (FC) antiretroviral (ARV) drug products for which the individual drug product components of the combination are already FDA-approved. The guidance revises and when finalized will replace a final guidance issued in 10/2006.

Significant changes from the 2006 guidance are:

  • addition of information about ARV drug products to prevent HIV infection;
  • deletion of references to co-packaged products and focus on SE ARV and FC ARV drug products currently most needed under PEPFAR (President’s Emergency Plan for AIDS Relief);
  • inclusion of a subsection that describes the processes for making changes to applications after tentative approval;
  • addition of updated descriptions of regulatory requirements and procedures in the main text of the guidance and deletion of Attachment A, which provided hypothetical scenarios;
  • reference to other FDA guidances for common regulatory topics instead of repeating information;
  • addition of updated information in the section on chemistry, manufacturing, and controls to be consistent with other guidances published after 2006;
  • deletion of Attachment B, which listed examples of two and three FCs supported by clinical data; and
  • deletion of Attachment C, which listed combinations that were not acceptable for FC or co-packaging.

“This guidance is not an exhaustive document on FDA’s current thinking regarding the development and review of ARV drug products eligible for procurement under PEPFAR,” it says. “Applicants can refer to other guidances cited in this document or seek advice from FDA when questions arise regarding specific drug development programs.”

The guidance includes an Introduction; Background on HIV Treatment, HIV Prevention, and PEPFAR; General Considerations; Clinical Considerations; Clinical Pharmacology and Biopharmaceutics; Chemistry, Manufacturing, and Controls; Labeling and Prescribing Information; and Other Regulatory Considerations.

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