Roche To Test Arthritis Drug Actemra for COVID-19 PneumoniaBy
Roche reports that it is working with the US Food and Drug Administration (FDA) to initiate a Phase III clinical trial to evaluate the safety and efficacy of Roche’s Actemra/RoActemra (tocilizumab), a drug to treat certain forms of arthritis, for treating severe pneumonia caused by the novel coronavirus (COVID-19).
Roche has launched the clinical trial in collaboration with the Biomedical Advanced Research and Development Authority, a part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response. The randomized, double-blind, placebo-controlled Phase III clinical trial will evaluate the evaluate Actemra/RoActemra plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.
Actemra/RoActemra is an interleukin-6 (IL-6) receptor antagonist used to treat moderately to severely active rheumatoid arthritis, giant cell arteritis, active polyarticular juvenile idiopathic arthritis, and active systemic juvenile idiopathic arthritis.
Roche says this is the first global study of Actemra/RoActemra in this setting and is expected to begin enrolling as soon as possible in early April with a target of approximately 330 patients globally, including the US. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables.
To date, there are several independent clinical trials exploring the efficacy and safety of Actemra/RoActemra for the treatment of patients with COVID-19 pneumonia. Actemra/RoActemra has been included in the 7th updated diagnosis and treatment plan for COVID-19 issued by China’s National Health Commission (NHC) on March 3, 2020.
Roche says this new trial is vital because there are no well-controlled studies and limited published evidence on the safety or efficacy of Actemra/RoActemra in the treatment of patients suffering from COVID-19. In addition, Actemra/RoActemra is not currently approved for this use by any health authorities, including the FDA.
In addition to initiating this trial, Roche received FDA Emergency Use Authorization for its Cobas® SARS-CoV-2 Test on March 13, 2020, to detect the novel virus that causes COVID-19 disease.