FDA Approves Tocilizumab as First Monoclonal Antibody Treatment of COVID-19

The FDA has approved tocilizumab (Actemra; Genentech) for the intravenous (IV) treatment of COVID-19 in individuals who are hospitalized and are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. Tocilizumab is the first FDA-approved monoclonal antibody treatment of COVID-19, recommended for use as a single 60-minute IV infusion.

“With new variants emerging, FDA-approved treatments including [tocilizumab] remain essential to the continued fight against COVID-19,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech, in a statement. “[Tocilizumab] 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.”

Investigators evaluated tocilizumab for the treatment of COVID-19 in 4 randomized, controlled studies (NCT04381936, NCT04372186, NCT04320615, and NCT04409262) in more than 5500 individuals who were hospitalized. The results of the 4 studies showed that tocilizumab may improve outcomes in individuals who were receiving corticosteroids and required supplemental oxygen or breathing support.

The FDA approval is based on the results from the RECOVERY (NCT04381936) and the EMPACTA (NCT04372186) trials in particular. The EMPACTA trial was the first global, phase 3 study investigating COVID-19 that focused on individuals from underrepresented racial and ethnic groups. There were no new warnings or precautions related to tocilizumab noted in the trials, with the most common adverse events being anxiety, constipation, diarrhea, hypertension, insomnia, nausea, and urinary tract infection.

Tocilizumab is the first humanized interleukin-6 receptor antagonist and has also been approved for the treatment of individuals with moderately active rheumatoid arthritis who have used 1 or more disease-modifying antirheumatic drugs, including methotrexate, that did not offer enough relief.

The approval follows the FDA’s emergency use authorization (EUA) issued in June 2021 for the drug in hospitalized adults and children aged 2 years and older with COVID-19. However, the FDA approval does not include individuals aged 2 years to less than 18 years. The EUA for this age range currently remains in place after the FDA approval of tocilizumab for adults.

Tocilizumab is approved for use for COVID-19 in the United States, 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 individuals who are hospitalized with severe or critical COVID-19. WHO has also recommended and prequalified the drug.

Genentech and Roche said that the worldwide manufacturing capacity of tocilizumab has significantly increased in 2022, which resulted in tocilizumab IV and tocilizumab subcutaneous (SC) being available to meet patient demands. However, tocilizumab SC has not been authorized for the treatment of COVID-19 in the United States.

Reference

FDA approves Genentech’s Actemra for the treatment of COVID-19 in hospitalized adults. Business Wire. News release. December 21, 2022. Accessed December 22, 2022. https://www.businesswire.com/news/home/20221221005002/en