RA Treatment Authorized For Hospitalized Adults and Children with COVID-19
Switzerland-based Roche announced on June 25, 2021, that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for intravenous Actemra/RoActemra® (tocilizumab) for the treatment of COVID-19 in hospitalized adults and patients two years of age and older, who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
The FDA issued this EUA 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 of these clinical studies suggest that Actemra/RoActemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support. There have been no new safety signals identified for Actemra/RoActemra in any of these studies.
The most common adverse reactions seen (incidence ≥ 3%) are constipation, anxiety, diarrhea, insomnia, hypertension, and nausea.
Actemra/RoActemra is approved in 116 countries. The FDA approved Actemra in 2010 for the treatment of severe rheumatoid arthritis.
“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, in a related press statement.
The U.S. FDA Letter of Authorisation and Fact Sheets for patients and health care professionals are available for download with the latest information on this EUA.
In these exceptional times, Roche stands together with society, governments, healthcare providers, and all those working to overcome the pandemic. For more information on how Roche is responding to the global COVID-19 pandemic, please visit this COVID-19 response page.