The Food and Drug Administration (FDA) approved a monoclonal antibody from Roche to treat COVID-19 in adult hospital patients on Wednesday, the company said.
The drug, called Actemra, was originally approved in 2010 to treat adult patients with moderate to severe rheumatoid arthritis. The company states that this is the first monoclonal antibody approved by the FDA to treat patients with severe COVID-19 cases.
“Actemra is the first monoclonal antibody approved by the FDA to treat patients with severe COVID-19 and represents an important option for hospital patients and their healthcare providers, who remain at the forefront of treating COVID-19,” said Levi Garraway, Chief Medical Officer of Roche, in a statement.
The drug is intended for the treatment of COVID-19 in adult hospital patients who are receiving certain steroids and require supplemental oxygen or mechanical ventilation, or are being treated with life-saving extracorporeal membrane oxygenation. It is recommended to use it as a single 60-minute intravenous infusion.
Last year, the FDA approved the emergency use of Actemra to treat severe COVID-19 cases in adults and children aged between 2 and 17 years. This approval remains in place, the company said.
Monoclonal antibodies work by mimicking natural antibodies produced by the immune system, which limits how much a virus can replicate in a person’s body. Before vaccines and treatments were available, monoclonal antibodies were one of the few available treatments for COVID-19 infections.
However, as new variants of the virus have become established, antibody treatments have become ineffective. The FDA suspended approval of bebtelovimab from Eli Lilly, the last remaining COVID-19 monoclonal antibody treatment, in November because it was not effective against the dominant BQ.1 and BQ.1.1 subvariants of the omicron variant of the virus.