The U.S. Food and Drug Administration (FDA) has, for the first time, approved a monoclonal antibody to treat COVID-19 in hospitalized patients.
Healthcare company Roche’s Actemra (tocilizumab) intravenous (IV) was approved by the FDA to treat severe COVID-19 in adults, the company announced on Wednesday.
Specifically, the drug is approved in cases where the patient is hospitalized and is receiving systemic corticosteroids, as well as requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
It is the first FDA-approved monoclonal antibody to treat COVID-19, the company stated.
Monoclonal antibodies are laboratory-created proteins that mimic natural antibodies the body produces to fight off harmful pathogens, such as the SARS-CoV-2 virus that causes COVID-19.
Actemra does not directly target SARS-CoV-2 but addresses the inflammation that occurs from COVID-19 infection. The monoclonal antibody reduces inflammation by blocking the interleukin-6 receptor.
The drug is recommended to be administered as a single 60-minute IV infusion.
According to Roche, more than one million hospitalized COVID-19 patients have been treated with Actemra worldwide since the start of the pandemic.
The drug was previously FDA-authorized for emergency use in hospitalized adults and pediatric COVID-19 patients (above 2 years of age) back in June 2021.
Right now, the FDA has not approved Actemra to treat hospitalized patients aged 2 to under 18, but the Emergency Use Authorization (EUA) still applies.
Actemra is not authorized or approved for the treatment of outpatients with COVID-19.
According to Roche, Actemra is approved for use in more than 30 countries for patients hospitalized with severe COVID-19. This includes the European Union, Japan, the United Kingdom, New Zealand, Russia, and Brazil. It is also provisionally approved in Australia, and authorized for emergency use in Ghana, Mexico, and Korea for certain patients hospitalized with severe or critical COVID-19.
The drug has also been recommended and prequalified by the World Health Organization (WHO).
In the United States, Actemra is the seventh FDA-approved indication since it was launched in 2010. It has been approved for use against other inflammatory diseases, including rheumatoid arthritis.