Invivyd, a biotechnology company based in Massachusetts, today announced that it has submitted a request with the US Food and Drug Administration (FDA) for an emergency use authorization (EUA) for its monoclonal antibody to prevent COVID-19.
The drug, called VYD222, is a broadly neutralizing, half-life extended monoclonal antibody for pre-exposure use in immunocompromised adults and adolescents. In a statement, the company said the EUA filing is supported by a phase 3 trial and ongoing in vitro studies to assess its activity against SARS-CoV-2 variants such as JN.1. The clinical trials have been testing a 4,500-milligram dose given by intravenous infusion.
No approved monoclonal antibodies
Currently, there are no monoclonal antibodies authorized or approved by the FDA. In January 2023, the FDA pulled its EUA for an earlier monoclonal antibody preventive called Evusheld after data suggested that it was unlikely to be active against certain SARS-CoV-2 variants.
Dave Hering, MBA, Invivyd's chief executive officer, said, "We believe that the demonstrated durability of VYD222 is reflective of our strategy to select antibody candidates that target conserved epitopes to achieve our stated goal of keeping pace with viral evolution." He added that many immunocompromised people don't achieve full benefit from COVID-19 vaccines, and pre-exposure treatments can provide an important new prevention option.
If the drug is authorized, the company hopes to make VYD222 rapidly available soon afterward.