US FDA to phase out animal testing requirement for antibody therapies

The US Food and Drug Administration (FDA) announced the agency will adopt human-relevant testing strategies for evaluating antibody therapies and other drugs, a significant step towards meeting the agency’s commitment to replace the use of animals as advised in the FDA Modernization Act 2.0 and the FDA’s Predictive Toxicology Roadmap.

The agency said in its announcement it will rely on a range of approaches such as AI-based computational models, lab-grown human organoids, and real-world safety data gleaned from countries with similar regulatory standards.

PETA Science Consortium International has long advocated for the adoption of modern scientific methods in the drug development process. This includes funding to support these initiatives, such as creating fully human recombinant monoclonal antibodies capable of neutralising diphtheria toxin, as well as proposing a novel, non-animal, pre-clinical testing approach to evaluate safety. Read more about our work on non-animal antitoxin development here.