Roche received U.S. FDA Emergency Use Authorization (EUA) for intravenous Actemra/RoActemra (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric patients (two years and older) who are receiving systemic corticosteroids and require supplemental oxygen. The EUA is based on results from four randomized, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalized patients. The results suggest that Actemra/RoActemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.
 
“Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, we continue to see new hospitalizations from severe forms of the disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are pleased that Actemra/RoActemra is now authorized as an option that may help improve outcomes for adults and children hospitalized with COVID-19 in the United States.”

Actemra/RoActemra was the first humanised interleukin-6 (IL-6) receptor antagonist approved for the treatment of moderate to severe active rheumatoid arthritis (RA).