Roche’s Actemra (tocilizumab) has been approved by the US Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalised adults, the company announced.
Specifically, Actemra is indicated for patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation and is recommended for use as a single 60-minute intravenous infusion.
The company’s application was supported by the results of four randomised, controlled studies in more than 5,500 hospitalised which altogether showed that Actemra may 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, as well as the EMPACTA trial, the first global, phase 3 study in COVID-19 to focus on patients from underrepresented racial and ethnic groups.
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.
The use of Actemra to treat hospitalised patients aged two to less than 18 years is not FDA approved, but the EUA for this age group currently remains in place.
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.”
Last month, Sobie’s Kineret (anakinra) was granted EUA by the FDA for the treatment of COVID-19 in hospitalised adults with pneumonia requiring supplemental oxygen who are at risk for progressing to severe respiratory failure.
The FDA’s decision was based on positive results from the SAVE-MORE phase 3 trial which found that early treatment of COVID-19-hospitalised patients with Kineret showed considerable efficacy and reduced the risk of disease progression by 64%.
Like Actemra, which was approved in 2010 to treat rheumatoid arthritis, Kineret has been on the US market for more than two decades for the treatment of RA, and has been indicated for a variety of other inflammatory conditions over the years.