FDA Updates Fact Sheets for Monoclonal Antibodies Used to Treat COVID-19

March 18, 2021 – The U.S. FDA has authorized revisions to fact sheets for healthcare providers on using the following monoclonal antibody (mAb) therapies to treat COVID-19 caused by the virus SARS-CoV-2:

These mAb therapies have been granted Emergency Use Authorization to treat mild to moderate COVID- 19 in patients 12 years of age and older who weigh at least 40kg (88 pounds) and are at high risk of progressing to severe COVID-19 and/or hospitalization. Revisions to their fact sheets provide information on the susceptibility of SARS-CoV-2 variants to each therapy.

Monoclonal antibodies are laboratory-made drugs that mimic the action of the body’s immune system, and in some patients may help prevent a worsening of COVID-19. However, coronaviruses like SARS-CoV- 2 typically mutate over time. While normal, this process can lead to variants that are resistant to current treatments. The FDA advises healthcare providers to consider the prevalence of mAb resistant variants of SARS-CoV-2 in their area, if data is available, when evaluating treatment options for COVID-19 patients.

A full copy of the announcement regarding updated mAb fact sheets is available on the FDA’s website.