SOUTH SAN FRANCISCO (dpa-AFX) - Swiss drug maker Roche Group (RHHBY) and its affiliate Genentech announced Thursday that they are working with the U.S. Food & Drug Administration to initiate a randomized, double-blind, placebo-controlled Phase III clinical trial of Actemra/RoActemra in hospitalized patients with severe COVID-19 Pneumonia.
The trial is in collaboration with the Biomedical Advanced Research and Development Authority or BARDA, a part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response or ASPR.
The trial will evaluate the safety and efficacy of Actemra/RoActemra (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.
Actemra is part of a co-development agreement with Chugai Pharmaceutical Co. and has been approved in Japan since June 2005. Actemra is approved in the European Union, where it is known as RoActemra, and several other countries.
The company noted that this is the first global study of Actemra 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 United States.
The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit variables.
Levi Garraway, chief medical officer and head of Global Product Development, said, 'In these unprecedented times, today's announcement is an important example of how industry and regulators can collaborate quickly to address the COVID-19 pandemic, and we will share the results as soon as possible.'
The company noted that there are several independent clinical trials exploring the efficacy and safety of Actemra for the treatment of patients with COVID-19 pneumonia. Actemra has been included in the 7th updated diagnosis and treatment plan for COVID-19 issued by China's National Health Commission on March 3.
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