A clinical trial to evaluate the safety and efficacy of intravenous Actemra (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia has been approved by the US FDA.
The randomised, double-blind, placebo-controlled Phase III trial is run by Roche member Genentech in collaboration with the Biomedical Advanced Research and Development Authority (BARDA).
To further support US COVID-19 response efforts, Genentech will provide 10,000 vials of Actemra to the US Strategic National Stockpile for potential future use at the direction of the US Department of Health and Human Services (HHS).
“We thank the FDA for rapidly expediting the approval of this clinical trial to evaluate Actemra in critically ill patients suffering from pneumonia following coronavirus infection and we’re moving forward to enroll as quickly as possible,” said Genentech CEO, Alexander Hardy.
“Conducting this clinical trial in partnership with BARDA and providing Actemra to support the national stockpile, through the efforts of Secretary Azar and HHS, are important examples of how the U.S. government the biotechnology industry and healthcare communities are working together in response to this public health crisis.”
To date, several independent clinical trials have begun globally to explore the efficacy and safety of Actemra for the treatment of patients with COVID-19 pneumonia.
However, this new trial is vital because there are no well-controlled studies and limited published evidence on the safety or efficacy of Actemra in the treatment of patients suffering from COVID-19.
In addition, Actemra is not currently approved for this use by the FDA.