The U.S. FDA has approved Roche's arthritis drug Actemra for emergency use to treat hospitalized COVID-19 patients.
The EUA was issued to Genentech, a subsidiary of Roche Holding, and 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 of these studies suggest that the injection may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.
Last July, the COVACTA trial was the first to report data and it wasn't favorable — Actemra failed to beat placebo at significantly improving clinical status among patients with severe COVID-19-related pneumonia. Recently, Roche shared the data from the REMDACTA trial, which found that pairing Actemra with Gilead Sciences’ remdesivir didn’t reduce the time severe COVID-19 patients had to stay in hospital compared with remdesivir alone.
But yet, the large-scale RECOVERY trial led by the U.K.’s National Institute for Health Research found that the addition of Actemra could slightly lower the chance of progressing to invasive ventilation or death. The smaller, Roche-sponsored EMPACTA study also met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra plus standard of care were 44% less likely to progress to mechanical ventilation or death.
The drug, an IL-6 inhibitor, was first approved in January 2010 for the treatment of rheumatoid arthritis and since racked up approvals for the treatment of several types of arthritis as well as cytokine release syndrome. This past March, the drug became the first biologic approved by the FDA to slow the decline in patients with a rare form of lung disease.