FDA Update-FDA Issues Policies to Guide COVID-19 Treatment Development

FDA Issues Policies to Guide COVID-19 Treatment Development

On February 22, 2021 the FDA released two guidances regarding the development of COVID-19 drugs. The first guidance specifically deals with the development of monoclonal antibody products, while the second guidance is focused on drugs that treat or prevent COVID-19. These guidances contain non-binding recommendations for sponsors to consider.

Within the guidance regarding monoclonal antibody products, the FDA provided the following guiding principles for sponsors to follow:

• The FDA will streamline the data needed to develop these products and will expedite review of the data
• The FDA will be judging the product’s coverage of multiple variants of the SARS-CoV-2 virus
• The FDA strongly recommends that the product be developed with the expectations that they will be combined with other similar products. They encourage collaboration between sponsors of individual products to address this.

Following these principles, the FDA provided some considerations for development programs to support use under an EUA. These considerations go through the Chemistry, Manufacturing, Controls, Pharmacology Toxicology, Virology and Clinical portions of the development cycle for monoclonal antibody products.

The second guidance provided by the FDA is to assist sponsors in the clinical development of drugs for treatment or prevention of COVID-19 not including preventative vaccines or convalescent plasma. The first set of recommendations the FDA makes is for trials of treatment drugs and how they should be run. This begins with the selection of people who should be within the studies to test the drug. The guidance then issues considerations about the trial design and the conduct of the trial followed by considerations on the efficacy endpoints of the drug. The section regarding treatment drugs ends safety and statistical considerations for the study. For the development of preventative drugs the FDA recommends that any sponsor call the agency early on in the planning of the trial stage and gives guidances on testing.

If you would like to read the FDA’s guidance on monoclonal antibody products click here and to read the broader guidance click here.

mdi is trying to keep on top of the FDA compliance as it is related to the Covid-19. If you require any assistance with FDA regulations or have any questions regarding EUAs during the COVID-19 emergency please reach out to [email protected]