The FDA said June 24 it has authorized Genentech's Actemra for treatment of hospitalized COVID-19 patients.
Actemra, an intravenous infusion drug with the generic name tocilizumab, is FDA-approved to treat several inflammatory diseases, including rheumatoid arthritis. Actemra is a monoclonal antibody that reduces inflammation.
The FDA gave emergency use authorization for the drug to be used in hospitalized COVID-19 patients who are also on corticosteroids and require supplemental oxygen or ventilation. It's not authorized for use in outpatients.
The agency said the authorization is based on the results of four clinical trials. In trials, Actemra in combination with corticosteroids was shown to reduce the risk of death after 28 days and decrease the amount of time patients remained hospitalized. It also decreased the risk of patients being placed on ventilators.
"Although vaccines have been successful in decreasing the number of patients with COVID-19 who require hospitalization, providing additional therapies for those who do become hospitalized is an important step in combating this pandemic," Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research, said in a news release.
Read the FDA's full news release here.