Roche Actemra gets USFDA okay to treat COVID in hospitalised adults

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.

Read also: Roche gets USFDA priority review for Actemra to treat Covid-19