US FDA approves Roche’s COVID-19 antibody

A photograph shows the Swiss pharma giant Roche headquarters in Basel on Sept 28, 2021. (SEBASTIEN BOZON / AFP)

Roche Holding AG said on Wednesday the US Food and Drug Administration (FDA) had approved its monoclonal antibody for treating COVID-19 in hospitalized adult patients.

The intravenous anti-inflammatory drug, Actemra, is a monoclonal antibody that reduces inflammation and was approved in 2010 to treat rheumatoid arthritis. It is the first FDA-approved monoclonal antibody to treat COVID-19, Roche said.

The FDA authorized the emergency use of Actemra last year June to treat severe cases of COVID-19.

In November, the regulator pulled authorization for Eli Lilly and Co's COVID-19 monoclonal antibody treatment, bebtelovimab, saying it was not fighting the dominant BQ.1 and BQ.1.1 subvariants of Omicron as expected.

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The subvariants accounted for around 69 percent of the cases in the United States, per government data last week.

Roche said on Wednesday the drug was approved for COVID-19 patients receiving certain steroids and who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or life support equipment extracorporeal membrane oxygenation.