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US FDA authorises mAb for COVID-19 treatment

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The US Food and Drug Administration issued an emergency use authorisation (EUA) for the investigational monoclonal antibody (mAb) therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and paediatric patients.

Bamlanivimab is authorised for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalisation. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.

While the safety and effectiveness of this 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 not authorised for patients who are hospitalised due to COVID-19 or require oxygen therapy due to COVID-19. A benefit of bamlanivimab treatment has not been shown in patients hospitalised due to COVID-19.

An US FDA release cautions that mAbs, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalised patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

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