FDA Approves Actemra for the Treatment of COVID-19 in Hospitalized Adults

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Genentech announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra® (tocilizumab) intravenously (IV) for the treatment of COVID-19 in hospitalized adult patients receiving systemic corticosteroids who require supplemental oxygen, noninvasive or invasive. Mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is the first FDA-approved monoclonal antibody for the treatment of COVID-19 and is recommended as a single, 60-minute intravenous infusion.

Image by Daniel Roberts from Pixabay

“As new variants emerge, FDA-approved therapies including Actemra remain essential to continue the fight against COVID-19,” said Levi Garroway, MD, PhD, chief medical officer and head of global product development. “Actemra is the first monoclonal antibody approved by the US Food and Drug Administration for the treatment of patients with severe COVID-19, and provides an important option for hospitalized patients and health care providers who remain on the front lines of treating COVID-19.”

Four randomized controlled studies have evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalized patients. Altogether, the results of these four studies (the University of Oxford-led RECOVERY trial, together with the global trials sponsored by Genentech, EMPACTA, COVACTA, and REMDACTA) showed that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support. . The FDA approval builds on the results of the RECOVERY trial, as well as the EMPACTA trial, the first global Phase III study in COVID-19 to focus on patients from underrepresented racial and ethnic groups. No new warnings and precautions related to Actemra have been identified in the COVID-19 studies. The most common side effects (incidence ≥ 3%) are constipation, urinary tract infection, high blood pressure, anxiety, diarrhea, insomnia, and nausea.

The FDA approval follows the Emergency Use Authorization (EUA) for Actemra in the hospital for adults and children (ages 2 and older) with COVID-19, which was granted in June 2021. Use of Actemra to treat people in Hospitalized adults ages 2 to under 18 are not approved by the FDA, however the EUA for this age group remains in effect after FDA approval for hospitalized adult patients.

More than a million people hospitalized with COVID-19 have been treated with Actemra worldwide since the start of the pandemic. Worldwide, Actemra has been approved for use in more than 30 countries for patients with severe COVID-19. In the United States, this is the seventh FDA-approved indication for Actemra since the drug was launched in 2010.

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