JW Jungwoo Pharmaceutical Starts Global Phase 3 Trial of Domestically Exclusive 'Actemra' for COVID-19

[Asia Economy Reporter Jihwan Park] Roche Group announced on the 19th (local time) that it has started a randomized, double-blind, placebo-controlled Phase 3 clinical trial in collaboration with the U.S. Food and Drug Administration (FDA) to evaluate the safety and efficacy of adding Actemra (tocilizumab) to standard treatment for adult patients hospitalized with severe COVID-19 pneumonia.

The company stated, "This is the first global study of Actemra in this setting, and we plan to begin enrolling approximately 330 patients worldwide, including in the United States, as soon as possible in early April." The primary and secondary endpoints include clinical status, mortality, mechanical ventilation, and intensive care unit (ICU) variables.

Dr. Levi Garraway of Roche Group said, "By initiating the Actemra clinical trial for patients hospitalized with COVID-19 pneumonia, we hope to firmly establish the potential role of Actemra in fighting the disease," adding, "Today's announcement during this unprecedented time is an important example of how the industry and regulatory agencies can rapidly collaborate to address the pandemic challenges of COVID-19, and we will share results as quickly as possible."

So far, several independent clinical trials have been conducted to assess the efficacy and safety of Actemra for treating COVID-19 pneumonia patients. Actemra was included in the 7th edition of the COVID-19 diagnosis and treatment plan issued by the National Health Commission (NHC) of China on March 3.

According to foreign media reports, in an unofficially evaluated Chinese trial, 21 COVID-19 patients experienced a rapid reduction in fever, 15 out of 20 patients (70.0%) showed a decreased need for oxygen therapy, and one patient did not require oxygen therapy at all.

Actemra is an antibody therapy that inhibits the binding of IL-6, a protein that causes inflammation in the body, to its receptor, and is considered effective in treating IL-6 related diseases such as rheumatoid arthritis.

However, to date, there is no clear evidence of the safety and efficacy of Actemra in treating patients suffering from COVID-19, and its use has not been approved by any health authorities, including the U.S. FDA.

This content was produced with the assistance of AI translation services.