FDA approves new monoclonal antibody for hospitalized COVID-19 patients

The Food and Drug Administration (FDA) on Wednesday approved a monoclonal antibody from Roche to treat COVID-19 in hospitalized adult patients, the company announced.

The drug, called Actemra, was originally approved in 2010 to treat adult patients with moderate to severe rheumatoid arthritis. The company says that is the first FDA-approved monoclonal antibody intended to treat patients with severe cases of COVID-19.

“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,” Levi Garraway, Roche’s chief medical officer, said in a statement.

The drug is intended for the treatment of COVID-19 in hospitalized adult patients who are receiving certain steroids and require supplemental oxygen, mechanical ventilation or are on life support through extracorporeal membrane oxygenation. It is recommended for use as a single 60-minute IV infusion.

Last year, the FDA authorized the emergency use of Actemra to treat severe cases of COVID-19 in adults and children between the ages of 2 and 17. That authorization remains in place, the company said.

Monoclonal antibodies function by mimicking natural antibodies produced by the immune system, limiting how much a virus can replicate inside a person’s body. Before vaccines and treatments were available, monoclonal antibodies were one of the only treatments available for COVID-19 infections.

But as new variants of the virus have taken hold, antibody treatments have become ineffective. The FDA in November paused authorization of bebtelovimab from Eli Lilly, which was the last remaining COVID-19 monoclonal antibody treatment, because it was not effective against the dominant BQ.1 and BQ.1.1 subvariants of the virus’s omicron variant.