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The authorization is based on four studies that evaluated Actemra in more than 5,500 hospitalized patients.
FDA granted an Emergency Use Authorization (EUA) for Genentech’s Actemra (intravenous tocilizumab) to treat COVID-19 in hospitalized adults and pediatric patients 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 in more than 5,500 hospitalized patients.
“The results of these studies suggest that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support,” Genentech officials said in a statement.
Actemra, a humanized interleukin-6 (IL-6) receptor antagonist, is already approved to treat rheumatoid arthritis and other immune conditions.
“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, MD, PhD, chief medical officer and head of Global Product Development at Genentech, said in a statement. “We are pleased that Actemra is now authorized as an option that may help improve outcomes for adults and children hospitalized with COVID-19 in the United States.”
The company is committed to collaborating closely with its distribution partners to “enable access to Actemra in hospitals across the country to help adults and children with COVID-19, as well as people who depend on the medicine for its FDA-approved indication,” CEO Alexander Hardy said.
In the four studies, the most common adverse reactions were constipation, anxiety, diarrhea, insomnia, hypertension and nausea.
The RECOVERY Actemra study was led by researchers in the United Kingdom and included more than 4,000 hospitalized COVID-19 patients. Genentech-sponsored global trials included the placebo-controlled EMPACTA, COVACTA and REMDACTA studies.