RA Drug Launches Late-Stage Study To Treat COVID-19 Patients
Genentech Actemra included in China’s National Health Commission COVID-19 diagnosis and treatment plan
A late-stage clinical trial is scheduled to launch in April 2020, which may bring to market a treatment for patients suffering from the COVID-19 disease.
California based Genentech announced that the company is working with the U.S. Food & Drug Administration (FDA) to initiate a Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority, to evaluate the safety and efficacy of Actemra® (tocilizumab) plus standard of care, in hospitalized adult patients with severe COVID-19 pneumonia.
Patients in this study will be followed for 60 days post-randomization, and an interim analysis will be conducted to look for early evidence of efficacy.
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.
The primary and secondary endpoints of this study include clinical status, mortality, mechanical ventilation, and intensive care unit (ICU) variables.
This new trial is important because there are no well-controlled studies and limited published evidence on the safety or efficacy of Actemra in the treatment of patients suffering from COVID-19, which is caused by the SARS-CoV-2 coronavirus.
And, Actemra is not currently approved for this use case by any health authorities, including the FDA.
To date, there are several independent clinical trials exploring the efficacy and safety of Actemra for the treatment of patients with COVID-19 pneumonia.
On March 3, 2020, Actemra has been included in the 7th updated diagnosis and treatment plan for COVID-19 issued by China’s National Health Commission.
Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development, said in a press release, “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.”
Actemra 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, such as methotrexate (MTX), that did not provide enough relief.
This medication is intended for use under the guidance of a healthcare practitioner, as Actemra can cause serious side effects.
Actemra changes the way a patient’s immune system works. This can make a patient more likely to get infections or make any current infection worse. Some people taking Actemra have died from these infections.
Actemra is approved in the European Union, where it is known as RoActemra, and several other countries, including China, India, Brazil, Switzerland, and Australia.
For more information on how Genentech is responding to the global COVID-19 disease pandemic, please visit our COVID-19 response page.
COVID-19 therapeutic development news published by Precision Vaccinations.