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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.

READ MORE: US COVID-19 cases surpass 100m – Johns Hopkins University

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.