FDA approves Roche COVID-19 antibody

On Wednesday, the U.S. Food and Drug Administration (FDA) gave the green light to the emergency use of Roche Holding AG’s monoclonal antibody, Actemra, for treating hospitalized adult patients with COVID-19. This is the first monoclonal antibody approved for treating this virus.

Actemra is an intravenous anti-inflammatory drug that was approved in 2010 for treating rheumatoid arthritis. Last June, the FDA granted authorization for the emergency use of Actemra in severe cases of COVID-19.

However, the FDA has recently pulled authorization for Eli Lilly and Co's COVID monoclonal antibody treatment, bebtelovimab, as it was not fighting the dominant BQ.1 and BQ.1.1 subvariants of Omicron as expected.

The FDA has now approved Actemra for hospitalized patients who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or life support equipment extracorporeal membrane oxygenation.

This is good news for those hospitalized with COVID-19, as there is now an approved monoclonal antibody for treating the virus. However, it is important to remember to follow the guidelines set by local governments to help prevent the spread of the virus, such as wearing masks, social distancing, and washing hands.


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