Genentech Actemra Gets FDA Emergency Use Authorization for Covid Treatment

 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for intravenous Actemra® (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric patients (2 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 EUA is based on results from four randomized, controlled studies that evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalized patients. The results of these studies suggest that Actemra 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., chief medical officer and head of Global Product Development. “We are pleased that Actemra is now authorized as an option that may help improve outcomes for adults and children hospitalized with COVID-19 in the United States.”

https://www.businesswire.com/news/home/20210624006034/en/Genentech%E2%80%99s-Actemra-Receives-FDA-Emergency-Use-Authorization-for-the-Treatment-of-COVID-19-In-Hospitalized-Adults-and-Children