Medicines Healthcare Products Regulatory Agency
Details
The evolution and spread of the original SARS-CoV-2 virus - and subsequent variants of the virus creating cyclical waves of infection - has demanded the rapid development and deployment of many antiviral therapeutic agents which presents a unique opportunity to assist in the management of the pandemic.
The viral escape mechanisms due to new variants have also presented unique challenges arising from the apparent loss of activity of therapeutic agents, such as the challenge of generating efficacy data in a timely fashion.
To address these challenges, the Antivirals and Therapeutics Taskforce established by the Department of Health and Social Care, together with academic expert pharmacologists, the UKHSA and the MHRA, held a workshop on 12 September 2022, involving several stakeholders, to identify knowledge gaps and encourage better utilisation of in vitro and Pharmacokinetic-Pharmacodynamic (PK-PD) analysis that could support the ongoing evaluation of the efficacy of several products.
This document describes the discussions and outputs from the workshop and subsequent interactions. It is intended to assist industry and the developers of products by providing a framework for the development of antiviral drugs and monoclonal antibodies (mAbs).