FDA has approved clinical trial for Tocilizumab to treat hospitalized patients with severe COVID-19 pneumonia
The FDA ( U.S. Food & Drug Administration ) has approved a randomized, double-blind, placebo-controlled phase III clinical trial in collaboration with BARDA ( Biomedical Advanced Research and Development Authority ) to evaluate the safety and efficacy of intravenous Tocilizumab ( Actemra; European Union: RoActemra ) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia.
Several independent clinical trials have begun globally to explore the efficacy and safety of Tocilizumab 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 Tocilizumab 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 Tocilizumab 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.
Tocilizumab 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 rheumatoid arthritis in 41 countries.
The Actemra RA subcutaneous clinical development program included two phase III clinical studies and enrolled more than 1,800 people with rheumatoid arthritis 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. ( Xagena )
Source: Genentech, 2020