Roche’s Actemra Granted US FDA Emergency Use Authorization for Treatment of Hospitalized COVID-19 Patients

Roche (Basel, Switzerland) has been issued an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults and children.

The FDA EUA has been granted for intravenous Actemra/RoActemra (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric 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 EUA 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 Actemra/RoActemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.

Actemra/RoActemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. Roche’s clinical trial program evaluated the safety and efficacy of Actemra/RoActemra in hospitalized patients with COVID-19. The four randomized, controlled studies included in the EUA submission investigated the safety and efficacy of Actemra/RoActemra in more than 5,500 hospitalized patients with COVID-19. The RECOVERY Actemra/RoActemra study was led by researchers in the UK and included more than 4,000 hospitalized COVID-19 patients. Roche-sponsored global trials included the placebo-controlled EMPACTA, COVACTA and REMDACTA studies. 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.

“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. “We are pleased that Actemra/RoActemra is now authorized as an option that may help improve outcomes for adults and children hospitalized with COVID-19 in the United States.”