Roche Launches First Global Phase III Clinical Trial of Tocilizumab for Severe COVID-19 Pneumonia
Roche
Oncology Drug Research, Development, and Manufacturing
FDA
U.S. Food and Drug Administration
Biomedical Advanced Research and Development Authority
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, provides a comprehensive, systematic approach to the development and procurement of necessary vaccines, drugs, therapeutics, and diagnostic tools for public health medical emergencies.
From Jike Pharmaceutical News
On March 19, Roche announced the initiation of a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the safety and efficacy of Actemra/RoActemra (tocilizumab) plus standard of care versus placebo plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia. The trial is being conducted in collaboration with the U.S. Food and Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (BARDA).
This is the first global study of Actemra/RoActemra in this setting, with enrollment expected to begin in early April. The study aims to recruit approximately 330 patients worldwide, including in the United States. Primary and secondary endpoints include clinical status, mortality, mechanical ventilation, and intensive care unit (ICU) variables.
To date, several independent clinical trials have explored the efficacy and safety of Actemra for treating patients with COVID-19 pneumonia. However, this new trial is critical, as there are currently no well-controlled studies and limited published evidence demonstrating the safety or efficacy of Actemra in treating patients with COVID-19.
Tocilizumab (Actemra/RoActemra) is the first approved monoclonal antibody acting as an IL-6 receptor antagonist. It was previously approved for the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA). Tocilizumab was approved in China in March 2013 for the treatment of rheumatoid arthritis, and in 2016 for the treatment of systemic juvenile idiopathic arthritis (sJIA). Tocilizumab has been included in the recommendations of the “Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7)” issued by the National Health Commission of China. Actemra/RoActemra has not yet been approved by any health authority, including the U.S. FDA, for this indication.
In addition to initiating this trial, the Roche cobas® SARS-CoV-2 test received FDA Emergency Use Authorization on March 13, 2020, for the detection of the novel coronavirus causing COVID-19 pneumonia.
References:
[1] Roche initiates Phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia . Retrieved 2020-03-19, from https://www.businesswire.com/news/home/20200318005822/en/Genentech-Initiates-Phase-III-Clinical-Trial-Actemra
Original Title: Breaking News! Roche Launches First Global Phase III Clinical Trial of Tocilizumab for the Treatment of COVID-19
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