A treatment for hospitalized COVID-19 patients was just approved by the U.S. Food and Drug Administration, according to a Wednesday press release from Roche, a Swiss healthcare company.
It said that the FDA approved Actemra, a brand of tocilizumab intravenous for the treatment for adult COVID-19 patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
“Actemra is the first FDA-approved monoclonal antibody for treating patients with severe COVID-19, providing an important option for hospitalized patients and their healthcare providers who continue to be on the frontlines treating COVID-19,” said Roche Chief Medical Officer and Head of Global Product Development Levi Garraway.
Through four trials that included more than 5,500 patients, researchers found that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support. It is also used as an arthritis treatment.
According to the Johns Hopkins Arthritis Center, it is in a class of drugs called biologics. It blocks a substance called interleukin-6 that is known to cause inflammation, the center explained.
“Interleukin (IL)-6 is a pleiotropic, proinflammatory cytokine produced by a variety of cell types, including lymphocytes, monocytes, and fibroblasts,” according to the National Institutes of Health. “Infection by SARS-CoV induces a dose-dependent production of IL-6 from bronchial epithelial cells.”
In June 2021, the FDA announced Emergency Use Authorization (EUA) for Actemra in hospitalized adults and children with COVID-19 who are at least two years old. Use of Actemra to treat hospitalized people ages 2 to less than 18 years old is not FDA approved.
“More than one million people hospitalized with COVID-19 have been treated with Actemra worldwide, since the beginning of the pandemic,” said Roche.
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