FDA issues EUA for Actemra/RoActemra (tocilizumab)
Roche said the U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for intravenous Actemra/RoActemra (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric patients (2 years old 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, Roche said.
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 antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The Actemra/RoActemra RA subcutaneous clinical development program included two phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries.