FDA approves first monoclonal antibody to treat COVID-19

The U.S. Food and Drug Administration (FDA) approved Genentech’s Actemra to treat COVID-19 in hospitalized adults. The drug is approved for adults “receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO),” the company announced.

Actemra (tocilizumab) “is the first FDA-approved monoclonal antibody to treat COVID-19.”

The drug is given to hospitalized adult patients via a single 60-minute IV infusion.

Genentech, a member of the Roche Group, is a member of the Biotechnology Innovation Organization (BIO).

“With new variants emerging, FDA-approved treatments including Actemra remain essential to the continued fight against COVID-19,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development.

The FDA made its decision based on “four randomized, controlled studies” evaluating the drug in more than 5,500 hospitalized patients. The study showed “that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.”

Since its launch in 2010, this is the seventh FDA-approved indication for Actemra in the United States.

Back in June 2021, the U.S. health regulator issued an emergency use authorization (EUA) to Actemra “for use in hospitalized adults and pediatric COVID-19 patients (above two years of age).” The World Health Organization (WHO) also recommended the drug at about the same time and prequalified it almost a year after.

Genentech’s medicine is approved in more than 30 countries – including the E.U., Japan, the U.K., New Zealand, Russia, and Brazil. In these countries, it is approved for patients hospitalized with severe COVID. Since the beginning of the pandemic, “more than one million people hospitalized with COVID-19 have been treated with Actemra.”

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