FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19

May 27th 2021

While much has been written about the various COVID-19 vaccines (prevention), including here are Speaking of Research, less emphasis has been placed on the treatment of COVID-19 patients—both earlier on in the pandemic and even at present. Part of this relates to some inherent skepticism of the value of using existing treatments for a new emergent disease. One of the primary issues with using drugs whose safety profile has not been extensively tested in relation to a new disease, is the potential for harm to the patient. However, in a time of crisis, with, to date, ~3.5 million deaths globally, some physicians have argued that they have failed in utilizing combination approaches to drugs to help individuals with severe COVID manage their symptoms and have testified before congress about this tragic failure. While we are unlikely to adjudicate these issues at this venue, it is worth mentioning if only to again highlight how partisan politics which sidelines science can lead to the catastrophic loss of life.

It is thus, timely, that:

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death. This includes, for example, individuals who are 65 years of age and older or individuals who have certain medical conditions. [emphases added]

Importantly, “laboratory testing showed that sotrovimab retains activity against the current circulating variants first reported in the United Kingdom, South Africa, Brazil, California, New York and India”. This knowledge of a highly efficacious treatment, which in addition to vaccinations (a prevention strategy for COVID) provides even more hope that we can draw this pandemic to a close.

~Speaking of Research