Coronavirus (COVID-19) Update: FDA Authorises Monoclonal Antibody for Treatment of COVID-19

The US FDA has issued an emergency use authorisation for investigational monoclonal antibody therapy bamlanivimab for treatment of mild-to-moderate COVID-19 in patients’ ≥12 years weighing ≥ 40 kg and at high risk for progressing to severe COVID-19 and/or hospitalisation.

SPS commentary:

Authorisation includes those who are 65 years of age or older, or who have certain chronic medical conditions. According to the FDA, while the safety and effectiveness of the investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalisation or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.

 

Bamlanivimab is however, not authorised for patients who are hospitalised due to COVID-19 or require oxygen therapy due to COVID-19; as benefit of bamlanivimab treatment has not been shown in patients hospitalised due to COVID-19.

 

US Food and Drug Administration