The indication makes tocilizumab the first monoclonal antibody to be granted full FDA approval to treat the pandemic virus.
The US Food and Drug Administration (FDA) has approved intravenous (IV) tocilizumab (Actemra) for the treatment of COVID-19 in hospitalized adults receiving additional care.
The approval, granted to Roche, makes tocilizumab the first monoclonal antibody approved by the FDA to treat the pandemic virus. It is recommended for use as a single 60-minute IV infusion in patients receiving systemic corticosteroids who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Tocilizumab has been assessed as a COVID-19 treatment across 4 randomized, controlled clinical trials involving 5500-plus hospitalized patients: Oxford University’s RECOVERY study, plus Roche-sponsored global studies EMPACTA, COVACTA, and REMDACTA. According to Roche, tocilizumab was associated with improved outcomes in treated patients additionally receiving supplemental oxygen or breathing support. The FDA approval was supported by data from the RECOVERY and phase EMPACTA trial.
The monoclonal antibody was previously granted Emergency Use Authorization (EUA) for the treatment of adults and children ≥2 years old with COVID-19 in June 2021. The EUA indication for pediatric and adolescent patient remains in place despite the approved marketed use for adults.
Utility and investigation of the interleukin-targeting therapy has been varied in past years; a subcutaneous injection regimen of tocilizumab was approved for the treatment of systemic sclerosis-associated interstitial lung disease in March 2021. It has been additionally approved for the treatment varying forms of psoriatic and rheumatic arthritis.
In a statement accompanying the approval, Levi Garraway, MD, PhD, Roche chief medical officer and head of Global Product Development, highlighted tocilizumab’s integral and novel role in combating severe cases of COVID-19.
“With new variants emerging, FDA-approved treatments including Actemra remain essential to the continued fight against COVID-19,” Garraway said. “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.”