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Roche’s Covid-19 antibody treatment gets FDA approval

covid 19

HQ Team

December 22, 2021: The US Food and Drug Administration (FDA) has approved Roche’s Actemra (tocilizumab) for treating COVID-19 in hospitalised adults.

Actemra is recommended for patients receiving systemic corticosteroids, requiring supplemental oxygen, and mechanical ventilation, and is given as a single 60-minute intravenous infusion.

The company carried out four randomised, controlled studies in more than 5,500 hospitalised patients, which showed Actemra could improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.

The FDA’s final decision was based on results from the University of Oxford-led RECOVERY trial and the EMPACTA trial, the first global, phase 3 study in COVID-19 to focus on patients from underrepresented racial and ethnic groups.

Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 and is recommended for use as a single 60-minute IV infusion.  

The approval follows the FDA’s Emergency Use Authorisation (EUA) for Actemra in hospitalised adults and children aged two years and older with COVID-19, which was granted in June 2021.

Globally, Actemra is approved for use in more than 30 countries for patients hospitalised with severe COVID-19, with over one million patients hospitalised with COVID-19 having been treated with Actemra worldwide since the beginning of the pandemic.

Commenting on the latest approval, Levi Garraway, chief medical officer and head of global product development, said: “With new variants emerging, FDA-approved treatments, including Actemra, remain essential to the continued fight against COVID-19.

“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.”

No new warnings and precautions related to Actemra in COVID-19 studies have been identified. 

The worldwide manufacturing capacity of Actemra has significantly increased in 2022.

It has also been recommended and prequalified by the World Health Organization.  

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