Roche announced today that it received FDA emergency use authorization (EUA) for intravenous Actemra/RoActemra in treating COVID-19.
Basel, Switzerland-based Roche’s Actemra/RoActemra (tocilizumab) drug received authorization to treat 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).
Actemra/RoActemra is 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, Roche said in a news release.
According to the release, Roche garnered authorization based on results from four randomized, controlled studies evaluating the treatment in more than 5,500 patients, with results demonstrating that the drug may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.
“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,” Roche CMO & head of global product development Dr. Levi Garraway said in the release. “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.”