FDA approves Roche’s Actemra for the treatment of COVID-19 in hospitalised adults

Thursday, December 22, 2022

Roche announced that the U.S. Food and Drug Administration (FDA) has approved Actemra® (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalised adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 and is recommended for use as a single 60-minute IV infusion.

“With new variants emerging, FDA-approved treatments including Actemra remain essential to the continued fight against COVID-19,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “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.”

Four randomised, controlled studies evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalised patients. Altogether, the results of these four studies (the University of Oxford-led RECOVERY trial, along with the Roche-sponsored global trials, EMPACTA, COVACTA and REMDACTA) showed that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support. The FDA approval is based on the results from the RECOVERY trial, as well as the EMPACTA trial, the first global, Phase III study in COVID-19 to focus on patients from underrepresented racial and ethnic groups. No new warnings and precautions related to Actemra in COVID-19 studies have been identified.

The FDA approval follows the FDA’s Emergency Use Authorization (EUA) for Actemra in hospitalised adults and children (ages 2 and older) with COVID-19, which was granted in June 2021. The use of Actemra to treat hospitalised people ages 2 to less than 18 years old is not FDA approved, however the EUA for this age group currently remains in place after the FDA approval for hospitalised adult patients.

More than one million people hospitalised with COVID-19 have been treated with Actemra worldwide, since the beginning of the pandemic. Around the world, Actemra is approved for use in more than 30 countries for patients hospitalised with severe COVID-19. In the United States, this is the seventh FDA approved indication for Actemra since the medicine was launched in 2010.

Roche stands together with society, governments, healthcare providers and all those working towards the common goal of overcoming the COVID-19 pandemic.

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