**Introduction **
Disease due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to be an important public health problem. This concept paper addresses the need to develop a guideline on the non-clinical and clinical evaluation of antiviral medicinal products and monoclonal antibodies intended for the treatment and/or prevention of coronavirus disease 2019 (COVID-19) for which there is currently no regulatory guideline in the European Union.
The scope of the guideline will be limited to antiviral medicinal products and monoclonal antibodies (mAbs) that are directed specifically against the viral target SARS-CoV-2. Medicinal products that target the host’s immune system (for example those blocking the angiotensin-converting enzyme 2 (ACE2) receptor or cytokines) will be out of scope of the document, as these require different considerations for evaluating their safety and efficacy. The development of vaccines to prevent COVID 19 will not be covered in this guideline.
Problem statement
This concept paper concerns the development of a scientific guideline on the non-clinical and clinical evaluation of antiviral medicinal products and monoclonal antibodies for the treatment and prevention of COVID-19.
During the declared public health emergency of SARS-CoV-2 and thereafter, the EMA Emergency Task Force (ETF) has responded and continues to respond to many requests for scientific advice concerning the development of antiviral medicinal products and monoclonal antibodies intended for the treatment and/or prevention of COVID-19. While the public health emergency has passed, the virus continues to evolve and to cause significant morbidity and variable mortality. There is a need for guidance built on experience so far that addresses appropriate and feasible clinical study designs, including study populations, endpoints and, where appropriate, choice of active comparators. Also, at a joint EMA/FDA Workshop in December 2022, immunobridging approaches for novel monoclonal antibodies that are manufactured on the same platform technology as approved monoclonal antibodies were agreed. Therefore, immunobridging strategies for monoclonal antibodies to expedite the development and access to mAbs for the prevention of COVID-19 will be discussed in the guideline.
Overall, considering all the abovementioned critical new aspects in the field of antiviral medicinal products and monoclonal antibodies directed against the viral target SARS-CoV-2 there is a need for the development of a guideline.
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