US okays Invivyd's Pemgarda to guard immunocompromised against COVID

2024-03-22

临床3期免疫疗法紧急使用授权临床结果

The FDA has issued an emergency-use authorisation (EUA) for Invivyd's monoclonal antibody Pemgarda (pemivibart/VYD222) as pre-exposure prophylaxis against COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise.

The green light offers a new preventive option for at-risk populations following the removal of AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab) from the US market early last year due to its lack of effectiveness against Omicron subvariants.

"Pemgarda's authorisation… marks strategic proof-of-concept for our platform approach designed to enable rapid, serial generation of durable antibodies targeting conserved viral epitopes," said CEO Dave Hering.

Invivyd said the EUA is based on positive immunobridging data from the ongoing Phase III CANOPY trial, as well as data showing that serum neutralising antibody titers against JN.1 were consistent with the titers levels linked to protection in prior clinical trials of adintrevimab (ADG20), which is the parent mAb for Pemgarda. JN.1 is currently the dominant variant circulating in the US according to estimates from the US Centers for Disease Control and Prevention (CDC).

More to follow.

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