Actemra for COVID-19: Roche says US FDA grants priority review

Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra/RoActemra (tocilizumab) intravenous for the treatment of COVID-19.

“The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalised with COVID-19,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development, Roche. “More than one million people with severe or critical COVID-19 have already been treated with Actemra/RoActemra worldwide, demonstrating the important role of this medicine in the fight against the pandemic.”

The sBLA submission is based on results from four randomised, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalised patients. Altogether, the results of these four studies (EMPACTA, COVACTA, REMDACTA, and RECOVERY) suggest that Actemra/RoActemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.2-5

In June 2021, Actemra/RoActemra received Emergency Use Authorization from the U.S. FDA and is currently approved for use in 16 countries around the world for defined patients hospitalised with severe or critical COVID-19.6,7 In February 2022, the World Health Organization (WHO) prequalified Actemra/RoActemra for patients with severe or critical COVID-19, supporting access to care in low- and middle-income countries.

About Actemra/RoActemra (tocilizumab) in COVID-19

Actemra/RoActemra is approved for use in multiple territories including the European Union, Japan, Bolivia, Chile, Guatemala, Ecuador, Honduras, Hong Kong, Myanmar, Peru, Philippines, the United Kingdom and Ukraine, provisionally approved in Australia, and authorised for emergency use in Ghana, Korea and the United States for defined patients hospitalised with severe or critical COVID-19. It has also been recommended and prequalified by the World Health Organization.

About the Actemra/RoActemra (tocilizumab) COVID-19 Clinical Trial Programme
Roche’s clinical trial programme evaluated the safety and efficacy of Actemra/RoActemra in hospitalised patients with COVID-19.

Actemra/RoActemra is not US Food and Drug Administration (FDA)-approved for this use and there is limited information known about the safety or effectiveness of using Actemra/RoActemra to treat people in the hospital with COVID-19.

COVACTA and EMPACTA were the first two global phase III, multicentre, randomised, placebo-controlled studies of Actemra/RoActemra in patients hospitalised with COVID-19 associated pneumonia. COVACTA was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services (HHS). EMPACTA aimed to address research questions about the safety and efficacy of Actemra/RoActemra in underserved populations by emphasising enrollment from minority patients often underrepresented in clinical trials.

Both studies were published in the New England Journal of Medicine. Roche also partnered with Gilead Sciences, Inc., on REMDACTA, a phase III, randomised, double-blind, multicentre study to evaluate the safety and efficacy of Actemra/RoActemra plus Veklury® (remdesivir), versus placebo plus Veklury, in hospitalised patients with severe COVID-19 associated pneumonia.