Invivyd Gains Alignment With FDA On Rapid Pathway For Options Against Symptomatic COVID-19

(RTTNews) - Invivyd (IVVD) announced general alignment with the FDA on an expedient, repeatable immunobridging pathway to future potential emergency use authorizations for serial, monoclonal antibodies for the prevention and treatment of symptomatic COVID-19. The pathway provides for the establishment of a registrational clinical trial protocol that could obviate the need to submit a new protocol for the evaluation of each new mAb, streamlining the process required to evaluate new mAbs in compact clinical programs envisioned to include hundreds of participants exposed to a new mAb, with the specific number of exposures to be determined in consultation with the FDA.

Utilizing the framework, Invivyd plans to rapidly move towards a registrational clinical trial of VYD2311 that evaluates intravenous and potentially other routes of administration.

For More Such Health News, visit rttnews.com.