FDA Approves Actemra for Hospitalized Patients with COVID-19

The FDA has approved Genentech’s Actemra (tocilizumab) intravenous to treat patients 18 years of age and older who are hospitalized with COVID-19. It is indicated for patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 and is recommended for use as a single 60-minute IV infusion. 

Levi Garraway, M.D., Ph.D.

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

Actemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved to treat adult patients with moderate to severe rheumatoid arthritis. The FDA approval for COVID-19 patients follows the FDA’s emergency use authorization (EUA) for Actemra in hospitalized adults and children (ages 2 and older) with COVID-19, which was granted in June 2021. The use of Actemra to treat hospitalized patients ages 2 to less than 18 years old is not FDA approved, however the EUA for this age group remains in place.

Since the beginning of the pandemic, more than 1 million people hospitalized with COVID-19 have been treated with Actemra worldwide.

Related: FDA Accepts sBLA for Actemra for Hospitalized COVID-19 Patients

The FDA approval is based on the results from the RECOVERY trial, as well as the EMPACTA trial, a global, phase 3 study in COVID-19 that focused patients from underrepresented racial and ethnic groups. These two studies and the COVACTA and REMDACTA trials evaluated Actemra in more than 5,500 hospitalized patients. The results of these four studies showed that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.

No new warnings and precautions related to Actemra in COVID-19 studies have been identified. The most common adverse reactions seen are constipation, urinary tract infection, hypertension, anxiety, diarrhea, insomnia and nausea.

Since the EUA approval in June 2021, Actemra has faced supply challenges. Genentech and Roche have indicated that worldwide manufacturing capacity of Actemra has significantly increased in 2022, resulting in all configurations of Actemra IV and Actemra subcutaneous (SC) being available at levels sufficient to meet patient demand.