The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for tocilizumab (Actemra®) for intravenous (IV) use to treat COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
The sBLA is 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, anxiety, diarrhea, insomnia, hypertension and nausea.
“The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalized with COVID-19,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “More than one million people with severe or critical COVID-19 have already been treated with Actemra worldwide, demonstrating the important role of this medicine in the fight against the pandemic.”
In June 2021, the FDA 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, noninvasive or invasive mechanical ventilation, or ECMO.
The FDA is expected to make a decision on approval in the second half of the year.
- US FDA grants Priority Review to Genentech’s Actemra for the treatment of COVID-19 in hospitalized adults. News release. Genentech. Accessed April 4, 2022. https://www.businesswire.com/news/home/20220403005023/en/U.S.-FDA-Grants-Priority-Review-to-Genentech%E2%80%99s-Actemra-for-the-Treatment-of-COVID-19-in-Hospitalized-Adults
- Actemra. Fact Sheet for Healthcare Providers: Emergency Use Authorization for Actemra® (tocilizumab). Genentech; 2021. Accessed April 4, 2022. https://www.gene.com/download/pdf/actemra_eua_hcp_fact_sheet.pdf