FX.co ★ Invivyd Gains Alignment With FDA On Rapid Pathway For Options Against Symptomatic COVID-19

Invivyd (IVVD) has reached an agreement with the FDA to establish an efficient and repeatable immunobridging pathway for potential emergency use authorizations (EUA) of monoclonal antibodies (mAbs) for the prevention and treatment of symptomatic COVID-19. This pathway will allow for the creation of a registrational clinical trial protocol that can be used for evaluating new mAbs without the need for submitting separate protocols for each new candidate. This approach aims to streamline the evaluation process through compact clinical trials involving hundreds of participants, with the specific number of exposures to be determined in collaboration with the FDA.

Within this framework, Invivyd intends to swiftly initiate a registrational clinical trial of VYD2311, exploring both intravenous and potentially other administration routes.

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