FDA Grants Priority Review to Tocilizumab for Treatment of COVID-19 in Hospitalized Adults

The FDA has accepted a supplemental biologics license application (sBLA) and granted a priority review for tocilizumab (Actemra/RoActemra, Roche) for the treatment of COVID-19 in individuals who are hospitalized and receiving systemic corticosteroids and require extracorporeal membrane oxygenation, invasive or non-invasive mechanical ventilation, or supplemental oxygen.¹

A decision on the FDA approval is expected in the second half of 2022.¹

“The high rate of unvaccinated people will continue to put a strain on hospitals and health care systems around the world, furthering the need for effective treatments for patients hospitalized with COVID-19,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, said in a statement.1 “More than 1 million people with severe or critical COVID-19 have already been treated with tocilizumab worldwide, demonstrating the important role of this medicine in the fight against the pandemic”.¹

The sBLA is based on results from 4 controlled, randomized studies of more than 5500 individuals who were hospitalized and treated for COVID-19. The results of the 4 studies suggested that tocilizumab may improve outcomes in individuals receiving corticosteroids and requiring breathing support or supplemental oxygen.¹

In COVACTA and EMPACTA, the first 2 global phase 3 placebo-controlled, randomized, studies, investigators studied tocilizumab in individuals who were hospitalized with COVID-19-associated pneumonia.¹

COVACTA was conducted in collaboration with the Biomedical Advanced Research and Development Authority, which is part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.¹

EMPACTA was designed to address the efficacy and safety of tocilizumab in underserved populations by emphasizing enrollment from individuals who were minorities and underrepresented in clinical trials.¹

Additionally, REMDACTA was used to study the efficacy and safety of tocilizumab plus remdesivir (Veklury, Gilead) compared with the placebo and remdesivir in individuals who were hospitalized with severe COVID-19-associated pneumonia.¹

In the RECOVERY trial, investigators assessed the standard-of-care treatment for COVID-19 in hospitalized individuals in the United Kingdom compared with the standard of care and tocilizumab.²

In June 2021, tocilizumab received emergency use authorization from the FDA and is approved for use in 16 countries for patients hospitalized with critical or severe COVID-19.¹

In February 2022, the World Health Organization (WHO) prequalified tocilizumab for individuals with critical COVID-19, supporting access to care in low- and middle-income countries.¹

Additionally, Roche has established a comprehensive access approach to improve the availability of its COVID-19 medicines around the world, which includes providing tocilizumab at cost to WHO and partners of the Access to COVID-19 Tools Accelerator Initiative and implementing an international differentiated pricing strategy specifically designed to address needs during the pandemic and improve affordability.¹

Following the emergence of the Omicron variant in December 2021, WHO reported that interleukin-6 receptor blockers, such as tocilizumab, are expected to still be effective for managing individuals with severe COVID-19.¹

References

1. US FDA grants priority review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults. Roche. News release. April 4, 2022. Accessed April 5, 2022. https://www.roche.com/media/releases/med-cor-2022-04-04

2. RECOVERY Collaborative Group. Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomized, controlled, open-label, platform trial. Lancet. 2021;397(10285):1637-1645. doi:10.1016/S0140-6736(21)00676-0