New monoclonal antibody for hospitalised COVID-19 patients approved by FDA

pharmafile | December 22, 2022 | News story | Medical Communications  

The FDA has approved Roche’s monoclonal antibody which treats hospitalised adult patients with COVID-19. The antibody, Actemra, is already approved for the treatment of adult patients with moderate-to-severe rheumatoid arthritis, and is now the first monoclonal antibody approved by the FDA for the treatment of COVID-19.

Patients are recommended to receive the drug through a single 60-minute intravenous infusion. It is intended for adult patients with COVID-19 who are already being treated with certain steroids and are requiring supplemental oxygen, mechanical ventilation, or are on life support through extracorporeal membrane oxygenation (ECMO). The drug was approved last year for emergency use to treat severe COVID-19 cases in adult patients and paediatric patients between 2 and 17.

Monoclonal antibody drugs work by mirroring the response of natural antibodies produced by the patient’s immune system, meaning there is a limit to how much the virus can replicate within the body: these were the key treatments for COVID-19 before vaccines had been developed. However, with new variants of the virus, various antibody treatments have been rendered ineffective.

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Levi Garraway, Roche’s chief medical officer, commented: “Actemra is the first FDA-approved monoclonal antibody for treating patients with severe COVID-19, providing an important option for hospitalised patients and their healthcare providers who continue to be on the frontlines treating COVID-19.”

 

Betsy Goodfellow


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