Today, the Food and Drug Administration of the United States takes on a revolutionary measure to advance public health by replacing animal tests in the development of monoclonal therapies on antibodies and other drugs with more efficient and relevant human methods. The new approach is designed to improve drug safety and speed up the evaluation process, while reducing animal experimentation, lowering research and development costs (R&D), and ultimately, drug prices.

The FDA animal test requirements will be reduced, refined or potentially replaced using a range of approaches, including calculation models based on toxicity AI and cell lines and laboratory toxicity tests (new approach methodologies, NAMS data). The implementation of the diet will start immediately for the applications of survey on new drugs (IND), where the inclusion of NAMS data is encouraged and is described in a roadmap also published today. To determine the efficiency, the agency will also begin to use pre -existing and real security data from other countries, with comparable regulatory standards, where the drug has already been studied in humans.

“For too long, Drug Manufacturers have performed Additional Animal Testing of Drugs that Have Data in Broad Human Use Internationally. This initiative Marks a Paradigm Shift in Drug Evaluation and Holds Promise to Accelerate Cures and Meaningful Treatments for Americans While Reducing Animal Use,” Said Fda Commissioner Martin A. Makary, MD, MPH “By Leveraging Ai-Based Computational Modeling, Human Organ Model-Based Lab Testing, and Real-World Human Data, we can obtain safer treatments to patients faster and more reliably, while reducing R&D costs and drug prices.

Key benefits of replacing animal tests in the evaluation of the safety of monoclonal antibodies:

• Advanced computer simulations: The roadmap encourages developers to take advantage of computer modeling and artificial intelligence to predict the behavior of a drug. For example, software models could simulate how a monoclonal antibody is distributed through the human body and reliably predict the side effects according to this distribution as well as the molecular composition of the drug. We believe that this will considerably reduce the need for animal tests.
• Laboratory models based on humans: FDA will promote the use of human “organoids” cultivated in laboratory and organs on chip that imitate human organs – such as liver, heart and immune organs – to test the safety of drugs. These experiments can reveal toxic effects that could easily be not detected in animals, providing a more direct window on human responses.
• Regulatory incentives: The agency will work to update its guidelines to allow the examination of the data of these new methods. Companies that submit solid safety data from non -animal tests can receive a rationalized examination, because the need for certain animal studies is eliminated, which would encourage investments in modernized test platforms.
• Faster development of drugs: The use of these modern techniques should help accelerate the drug development process, allowing monoclonal antibody therapies to reach patients faster without compromising safety.
• Global leadership in regulation sciences: with this decision, the FDA reaffirms its role as world leader in modern regulatory sciences, establishing new standards for industry and encouraging the adoption of innovative and human test methods. In recent years, the Congress and the Scientific Community have requested more relevant human test methods. Today’s announcement is a stage in the FDA to its commitment to modernize the regulatory sciences as technology progresses.

Working in close partnership with federal agencies such as the National Institutes of Health, the National Toxicology Program and the Veterans Department, the FDA aims to accelerate the validation and adoption of these innovative methods through the Inter -listings coordination committee on the validation of alternative methods (ICCVAM). The FDA and the federal partners will organize a public workshop later this year to discuss the roadmap and collect the contributions of the stakeholders on its implementation. During the coming year, the FDA aims to launch a pilot program allowing developers of selected monoclonal antibodies to use a mainly non -animal test strategy, under a close consultation of the FDA. The results of a pilot study that accompanies it will shed light on wider policy changes and orientation updates that should be deployed in phases.

Commissioner Makary noted the large -scale importance of this proposal. “”For patientsThis means a more efficient pipeline for new treatments. This also means additional safety margin, as human -based test systems can better predict real world results. For animal welfareIt represents a major step towards the end of the use of laboratory animals in drug tests. Thousands of animals, including dogs and primates, could possibly be spared each year because these new methods take root. »»

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