FDA Approves Monoclonal for COVID-19 Treatment in Hospitalized Adults

The FDA has approved Roche’s Actemra (tocilizumab) intravenous (IV) monoclonal antibody for the treatment of COVID-19 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

This therapy is the first FDA-approved monoclonal antibody to treat COVID-19 and is recommended for use as a single 60-minute intravenous infusion.

“With new variants emerging, FDA-approved treatments including Actemra remain essential to the continued fight against COVID-19,” Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development, said in a statement.

Tocilizumab is a humanized interleukin-6 (IL-6) receptor antagonist that had previously been approved for various arthritis indications including rheumatoid arthritis, active polyarticular juvenile idiopathic arthritis, active systemic juvenile idiopathic arthritis as well as other indications.

Clinical Trials
The company said it used four randomized, controlled studies to evaluate tocilizumab for the treatment of COVID-19 in more than 5500 hospitalized patients. Altogether, the results of these four studies (the University of Oxford-led RECOVERY trial, along with the Roche-sponsored global trials, EMPACTA, COVACTA and REMDACTA) showed that the monoclonal antibody may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.

The FDA approval is based on the results from the RECOVERY trial, as well as the EMPACTA trial, the first global, phase 3 study in COVID-19 to focus on patients from underrepresented racial and ethnic groups. No new warnings and precautions related to tocilizumab in COVID-19 studies have been identified.

Working With WHO, Regeneron
The World Health Organization (WHO) has prequalified tocilizumab for use in patients with severe COVID-19, facilitating its availability in low- and middle-income countries. In addition, Roche said it has been improving access to the therapy by introducing an international differentiated pricing strategy, providing the medicine at cost for use in low- and middle-income countries and non asserting patents in these regions during the pandemic.

The company has also been collaborating with Regeneron to jointly develop the antibody combination Ronapreve (casirivimab and imdevimab, known as REGEN-COV in the US). It has been approved in multiple territories including the European Union, Japan, and Switzerland and authorized for emergency or temporary pandemic use in many countries including the US. In their statement, Roche said they are monitoring and assessing casirivimab and imdevimab’s neutralizing activity against emerging variants of concern and entered a dialogue with regulators and industry representatives to discuss the efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants.