The Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the intravenous administration of Actemra® (tocilizumab) to treat COVID-19 in hospitalized patients 2 years of age and older who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
The EUA was granted based on 4 randomized controlled clinical trials that evaluated the efficacy and safety of Actemra in more than 5500 hospitalized patients with COVID-19. The trials included the RECOVERY (ClinicalTrials.gov Identifier: NCT04381936), EMPACTA (ClinicalTrials.gov Identifier: NCT04372186), COVACTA (ClinicalTrials.gov Identifier: NCT04320615), and REMDACTA (ClinicalTrials.gov Identifier: NCT04409262) trials.
In the RECOVERY trial, hospitalized patients with severe COVID-19 pneumonia were randomly assigned 1:1 to receive either Actemra in addition to standard of care (n=2022) or standard of care alone (n=2094). Results showed that patients who received Actemra plus standard of care had a probability of death of 30.7% by day 28 compared with 34.9% for those treated with standard of care alone. The median time to hospital discharge was reported to be 19 days for Actemra-treated patients and more than 28 days for those receiving standard of care alone.
The EMPACTA trial included 389 hospitalized patients with COVID-19 pneumonia who were randomly assigned 2:1 to receive Actemra (n=249) or placebo (n=128). Findings showed that treatment with Actemra was associated with a reduction in progression to mechanical ventilation or death; 12% of patients treated with Actemra required mechanical ventilation or died by day 28 vs 19.3% of those who received placebo.
Findings from the COVACTA and REMDACTA trials contributed to the safety assessment of Actemra when used in the treatment of COVID-19. The most common adverse reactions reported were constipation, anxiety, diarrhea, insomnia, hypertension and nausea.
Additional information related to the emergency use of Actemra for COVID-19 can be found here.
- Coronavirus (COVID-19) update: FDA authorizes drug for treatment of COVID-19. [press release]. Silver Springs, MD: US Food and Drug Administration; June 24, 2021.
- Genentech’s Actemra receives FDA Emergency Use Authorization for the treatment of COVID-19 in hospitalized adults and children. [press release]. South San Francisco, CA: Genentech; June 24, 2021.