Roche Holding AG said late Wednesday that the Food and Drug Administration formally approved its monoclonal antibody for adults who have been hospitalized with severe COVID-19. Actemra received an emergency authorization in mid-2021 as a treatment for those 12 years old and older, and more than 1 million people have received treatment with the therapy, which is delivered to patients as one intravenous infusion that takes an hour. Actemra was originally approved to treat rheumatoid arthritis. Roche’s Swiss-listed shares are down 10.4% this year.
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