U.S. FDA approves Roche's COVID-19 antibody
22 Dec 2022
Emergency Use AuthorizationDrug Approval
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Source: Reuters
Dec 21 (Reuters) - Roche Holding AG (ROG.S) said on Wednesday the U.S. 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.
In November, the regulator pulled authorization for Eli Lilly and Co's (LLY.N) COVID monoclonal antibody treatment, bebtelovimab, saying it was not fighting the dominant BQ.1 and BQ.1.1 subvariants of Omicron as expected.
The subvariants accounted for around 69% of the cases in the United States, per government data last week.
Roche said on Wednesday the drug was approved for COVID patients receiving certain steroids and who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or life support equipment extracorporeal membrane oxygenation.
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