Genentech announced Monday that the FDA has approved a randomized, double-blind, placebo-controlled phase 3 clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of intravenous Actemra (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia.
Additionally, to further support U.S. COVID-19 response efforts, Genentech will provide 10,000 vials of Actemra to the U.S. Strategic National Stockpile for potential future use at the direction of the U.S. Department of Health and Human Services (HHS). The current U.S. supply of Actemra for approved indications is not expected to be impacted. Genentech has also been working with distributors to manage product supply to enable both Genentech and our distribution partners to quickly fill orders to meet patient needs.
“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,” Alexander Hardy, chief executive officer of Genentech, said in a company news release. “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.
The primary and secondary endpoints of the clinical trial include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables. Patients will be followed for 60 days post-randomization, and an interim analysis will be conducted to look for early evidence of efficacy.