Roche's Genentech on Wednesday announced that the U.S. Food and Drug Administration (FDA) has approved Actemra (tocilizumab), its intravenous monoclonal antibody medication for the treatment of COVID-19 in adult patients who have been hospitalized under specific conditions.
With the approval, patients to receive the medication are already receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 and is recommended for use as a single 60-minute intravenous infusion.
“With new variants emerging, FDA-approved treatments including Actemra remain essential to the continued fight against COVID-19,” Dr. Levi Garraway, chief medical officer and head of global product development at Roche, said in a statement.
Roche said that four randomized, controlled studies evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalized 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 on 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.