Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics

27 June 2022 — FDA issued draft guidance for comments by 25 September 2022.

This guidance provides recommendations to assist industry in the development of oligonucleotide therapeutics under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and 21 CFR parts 312 and 314. Specifically, this guidance represents the FDA’s recommendations for certain evaluations including pharmacokinetic, pharmacodynamic, and safety assessments during oligonucleotide therapeutic development, including: (1) characterizing the potential for QTc interval prolongation, (2) performing immunogenicity risk assessment, (3) characterizing the impact of hepatic and renal impairment, and (4) assessing the potential for drug-drug interactions. This guidance provides recommendations on when to conduct these assessments and what types of assessments are suitable to address these questions.

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