The Food and Drug Adminsitration (FDA) has approved Actemra (tocilizumab) for intravenous (IV) use to treat COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
The approval was supported by data from 4 randomized, controlled studies that evaluated tocilizumab, an interleukin-6 receptor antagonist, for the treatment of COVID-19 in more than 5500 hospitalized patients. The trials include the RECOVERY (ClinicalTrials.gov Identifier: NCT04381936), EMPACTA (ClinicalTrials.gov Identifier: NCT04372186), COVACTA (ClinicalTrials.gov Identifier: NCT04320615), and REMDACTA (ClinicalTrials.gov Identifier: NCT04409262) studies.
In the RECOVERY trial, hospitalized patients with severe COVID-19 pneumonia were randomly assigned 1:1 to receive either tocilizumab in addition to standard of care (n=2022) or standard of care alone (n=2094). Results showed the probabilities of dying at day 28 (primary endpoint) were estimated to be 30.7% in the tocilizumab plus standard of care arm and 34.9% in the standard of care arm alone (hazard ratio [HR], 0.85; 95% CI, 0.76-0.94; P =.0028). The median time to hospital discharge was reported to be 19 days for tocilizumab-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 tocilizumab (n=249) or placebo (n=128). Findings showed that treatment with tocilizumab was associated with a reduction in progression to mechanical ventilation or death; 12% (95% CI, 8.52-16.86) of patients treated with tocilizumab required mechanical ventilation or died by day 28 vs 19.3% (95% CI, 13.34-27.36) of those who received placebo.
Findings from the COVACTA and REMDACTA trials contributed to the safety assessment of tocilizumab when used in the treatment of COVID-19. The most common adverse reactions (incidence at least 3%) reported were constipation, urinary tract infection, hypertension, anxiety, diarrhea, insomnia, and nausea.
“With new variants emerging, FDA-approved treatments including Actemra remain essential to the continued fight against COVID-19,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “Actemra 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.”
FDA approves Genentech’s Actemra for the treatment of COVID-19 in hospitalized adults. News release. Genentech. Accessed December 21, 2022. https://www.businesswire.com/news/home/20221221005002/en/FDA-Approves-Genentech%E2%80%99s-Actemra-for-the-Treatment-of-COVID-19-in-Hospitalized-Adults.