FDA authorizes dosing change for monoclonal antibody treatment

The Food and Drug Administration yesterday authorized a revised dosing regimen for the combination monoclonal antibody therapy Evusheld when used to prevent COVID-19 in certain patients, citing data showing a higher initial dose may better prevent infection by certain omicron subvariants. Patients who received the previously authorized dose should receive an additional dose as soon as possible to raise their monoclonal antibody levels to those expected for patients receiving the higher dose, the FDA said. Because it is unclear which SARS-CoV-2 variant or omicron subvariant will become dominant in the United States over the next few months, the agency plans to monitor the situation and recommend timing for repeat dosing when more data are available.