Invivyd Discloses General Alignment With U.S. FDA On Repeatable, Expedient Emergency Use Authorization Pathway For Prevention And Treatment Of Symptomatic COVID-19, Based On Compact Clinical Programs To Establish Safety And Immunobridging
$IVVD
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
- Newly outlined pathway provides a practical, expedient, repeatable immunobridging approach to potential emergency use authorization of serial, novel monoclonal antibodies (mAbs) to prevent and treat COVID-19
- Pathway provides for the establishment of a master, registrational clinical trial protocol that is anticipated to streamline the evaluation of new mAbs in compact clinical programs
- Utilizing this framework, Invivyd plans to rapidly move towards a registrational clinical trial of VYD2311 that evaluates intravenous (IV) and potentially other routes of administration