Invivyd plans FDA accelerated-approval BLA filing for VYD2311 COVID antibody
IVVD•Invivyd plans to file a Biologics License Application for its COVID-19 antibody VYD2311 through the FDA’s Accelerated Approval Program, supported by two Phase 3 studies.
1. Filing plans
Invivyd expects its application to be supported by the Phase 3 DECLARATION and LIBERTY studies. Topline safety and immunogenicity data from DECLARATION are due in October; the company expects clinical efficacy data to be unblinded after accelerated approval, subject to event accrual.
