The indication covers hospitalized adults receiving systemic corticosteroids who need supplemental oxygen, noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
Tocilizumab targets the interleukin-6 receptor. It first won FDA approval to treat rheumatoid arthritis in 2010. Since then, the monoclonal antibody has won a string of additional indications related to arthritis, giant cell arteritis and CAR-T cell-induced cytokine release syndrome.
Interleukin-6 can act as a pro-inflammatory cytokine. Researchers have found elevated levels of the interleukin in patients with severe COVID-19.
The monoclonal antibody is the first to win approval for patients with severe COVID-19.
Before awarding the new indication, FDA reviewed data from four randomized trials testing tocilizumab in more than 5,500 patients hospitalized with COVID-19 infections. Those studies include the University of Oxford-led RECOVERY trial and the Roche-backed EMPACTA, COVACTA and REMDACTA studies.
The RECOVERY study, which enrolled participants from 131 sites in the UK, provided either tocilizumab or standard of care to hospitalized patients with COVID-19 with hypoxia and systemic inflammation. In that study, tocilizumab recipients had a significant reduction in 28-day mortality and a greater likelihood of hospital discharge than the standard-of-care group.
The EMPACTA study focused on hospitalized COVID-19-associated pneumonia patients who did not receive mechanical ventilation. Recipients of the drug had a lower likelihood of progression of mechanical ventilation or death. Tocilizumab recipients did not, however, have improved survival.
Results from the COVACTA study were less upbeat. In patients with COVID-19-associated pneumonia, the trial did not meet its primary endpoint of improved clinical status or a secondary endpoint of reduced patient mortality.
The REMDACTA study found the combination of tocilizumab and remdesivir did not influence the hospital discharge time compared to placebo plus remdesivir.
According to Roche, the results from the four studies showed that tocilizumab “may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.”
More than one million patients hospitalized with COVID-19 have received tocilizumab.
The drug has won approval in more than 30 countries for patients hospitalized with severe COVID-19.
In February 2022, the World Health Organization added tocilizumab to its list of prequalified COVID-19 therapies.
In June 2021, the FDA awarded emergency use authorization (EUA) to tocilizumab for treating COVID-19.
The drug was one of the first to emerge as a promising therapy for severe COVID-19.
Filed Under: Infectious Disease