FDA urges sponsors to find alternatives to nonhuman primates for toxicity studies

Regulatory NewsRegulatory News | 08 February 2022 |  By 

The US Food and Drug Administration (FDA) is urging sponsors to find alternatives to nonhuman primates (NHPs) in their nonclinical toxicology studies and is especially discouraging their use for small molecule development programs. The announcement was prompted by the limited availability of monkeys related to their demand for use in investigational COVID-19 treatments.
The recent announcement was made in an immediately effective guidance issued last week amid supply constraints for NHPs during the COVID-19 pandemic. The guidance was issued without public comment and is set to remain in effect throughout the duration of the COVID-19 public health emergency.
FDA said sponsors typically select the appropriate species for toxicology studies based on the species’ predictability to the human response, and weigh such factors as metabolic, pharmacokinetic, and pharmacologic similarities to humans.
The agency said that biological products typically “manifest their intended pharmacological activity in other primates, often making NHPs the only animal species that allows for toxicity testing of the biological product that is intended to be used in humans.”
Yet there are cases where a biological product may be pharmacologically active in other species. “If the biological products is active in other nonrodent species, the sponsor should conduct any warranted general toxicity studies in a nonrodent species other than the NHP,” FDA writes.
FDA said there are cases where it is “scientifically appropriate” for sponsors to conduct general toxicity studies in rodents if the biological product is active in a rodent on a well-characterized target, such as a vascular endothelial growth factor, or its receptor.
FDA is discouraging using monkeys for general toxicity assessments of small molecule drugs. For small molecules, NHPs are “generally not the only relevant nonrodent species.” The agency will allow their use only if sponsors offer a “scientifically compelling reason” for doing so.
FDA said it will revise the guidance within 60 days of the termination of the public health emergency.
Final guidance


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