Actemra is a humanised monoclonal antibody indicated for hospitalised adult patients receiving systemic corticosteroids and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)
Roche administration and R&D buildings. (Credit: F. Hoffmann-La Roche Ltd)
Swiss healthcare company Roche has received the US Food and Drug Administration (FDA) approval for Actemra (tocilizumab) to treat Covid-19 in hospitalised patients.
Actemra is a recombinant humanised monoclonal antibody that works as an interleukin 6 (IL-6) receptor antagonist, recommended as a single 60-minute intravenous (IV) infusion.
The FDA approval indicates the drug for hospitalised adults receiving systemic corticosteroids and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
It follows the FDA Emergency Use Authorization (EUA) in hospitalised adults and children, aged 2 years and above, with Covid-19, granted in June 2021.
Actemra was previously approved to treat different types of arthritis, including GCA, PJIA, SJIA, SSc-ILD, along with severe Covid-19.
In addition, the drug has also been prequalified by the World Health Organization, for the treatment of severe Covid-19 in low- and middle-income countries.
Roche chief medical officer and global product development head Levi Garraway 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.”
Roche’s Actemra was evaluated in four randomised, controlled studies, for the treatment of Covid-19 in more than 5,500 hospitalised patients.
They include the RECOVERY trial led by University of Oxford, along with EMPACTA, COVACTA, and REMDACTA trials sponsored by Roche.
In the four clinical trials, Actemra improved outcomes for patients, who are receiving corticosteroids and needs supplemental oxygen or breathing support.
The current FDA approval is supported by results from the RECOVERY and EMPACTA trials, in which no new warnings and precautions related have been identified.
Roche claims that Actemra has been used for treating more than one million people hospitalised with Covid-19, since the beginning of the pandemic.