Roche's IL-6 Receptor Inhibitor Actemra Receives FDA Emergency Use Authorization for Hospitalized Severe COVID-19 Patients

On June 25, 2021, Roche announced that the U.S. FDA granted an Emergency Use Authorization (EUA) for its intravenous IL-6 receptor inhibitor Actemra/RoActemra (tocilizumab) for the treatment of adult and pediatric patients aged two years and older who are hospitalized with COVID-19. These patients are receiving systemic corticosteroid therapy and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Patients with severe COVID-19 exhibit an overactive immune response. Tocilizumab is a humanized interleukin-6 (IL-6) receptor antagonist that binds to the IL-6 receptor to block the IL-6 signaling pathway, thereby reducing the pro-inflammatory response. It was previously approved by the FDA for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

This EUA was granted based on positive results from four randomized controlled clinical trials enrolling a total of over 5,500 patients, designed to evaluate the efficacy and safety of tocilizumab treatment in hospitalized patients with COVID-19. Among them, the RECOVERY trial, which enrolled 2,022 patients, demonstrated that tocilizumab improved patient survival rates, shortened the length of hospital stay, and reduced the need for mechanical ventilation.

In terms of safety, no new safety signals were identified in any of the studies. The most common adverse reactions (incidence ≥3%) were constipation, anxiety, diarrhea, insomnia, hypertension, and nausea.

Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche, stated: “Despite the worldwide availability of vaccines and the decline in COVID-19 deaths, we continue to see patients with severe COVID-19 requiring hospitalization. We are pleased that this authorization provides a new treatment option for these patients, which may help improve outcomes for adults and children hospitalized with COVID-19.”

References:

[1] Roche’s Actemra/RoActemra receives U.S. FDA Emergency Use Authorization for the treatment of COVID-19 in hospitalised adults and children. Retrieved June 25, 2021, from https://www.roche.com/media/releases/med-cor-2021-06-25.htm

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