Genentech, a member of the Roche Group, announced the US Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled phase III 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 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). The company has robust business continuity and mitigation strategies in place, and current US 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,” said Alexander Hardy, chief executive officer of Genentech. “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 US 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.
Genentech is initiating a randomized, double-blind, placebo-controlled phase III study (COVACTA) to evaluate the safety and efficacy of intravenous Actemra added to standard of care in adult patients hospitalized with severe COVID-19 pneumonia compared to placebo plus standard of care. The primary and secondary endpoints 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.
Actemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The extensive Actemra RA IV clinical development program included five phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. The Actemra RA subcutaneous clinical development program included two phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries.
Actemra subcutaneous injection is also approved for the treatment of adult patients with giant cell arteritis (GCA) and for patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA). In addition, Actemra is also approved in the IV formulation for patients two years of age and older with active PJIA, SJIA or CAR T cell-induced cytokine release syndrome (CRS). Actemra is not approved for subcutaneous use in people with CRS. It is not known if Actemra is safe and effective in children with PJIA, SJIA or CRS under two years of age or in children with conditions other than PJIA, SJIA or CRS.