Genentech Initiates Phase III Clinical Trial Of Actemra In Hospitalized Patients With Severe COVID-19 Pneumonia

SOUTH SAN FRANCISCO, CA, USA I March 18, 2020 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company is working with the U.S. Food & Drug Administration (FDA) to initiate a randomized, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR), to evaluate the safety and efficacy of Actemra® (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.

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 (ICU) variables.

"We are initiating a clinical trial to study Actemra for the treatment of people hospitalized with COVID-19 pneumonia, so that we can better establish the potential role for Actemra in fighting this disease," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “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.”

To date, 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 (NHC) on March 3, 2020.

However, this new trial is vital 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. In addition, Actemra 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 the cobas® SARS-CoV-2 Test on March 13, 2020, to detect the novel virus that causes COVID-19 disease. Learn more here.

For more information on how Genentech is responding to the global COVID-19 pandemic, please visit our COVID-19 response page.

About the Clinical Trial

Genentech is initiating a randomized, double-blind, placebo-controlled Phase III study (COVACTA) to evaluate the safety and efficacy of intravenous Actemra added to standard of care in adult patients hospitalized with severe COVID-19 pneumonia compared to placebo plus standard of care. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables. Patients will be followed for 60 days post-randomization, and an interim analysis will be conducted to look for early evidence of efficacy.

About Actemra

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 (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The extensive Actemra RA IV clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. The Actemra RA subcutaneous clinical development program included two Phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. Actemra subcutaneous injection is also approved for the treatment of adult patients with giant cell arteritis (GCA) and for patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA). In addition, Actemra is also approved in the IV formulation for patients two years of age and older with active PJIA, SJIA or CAR T cell-induced cytokine release syndrome (CRS). Actemra is not approved for subcutaneous use in people with CRS. It is not known if Actemra is safe and effective in children with PJIA, SJIA or CRS under two years of age or in children with conditions other than PJIA, SJIA or CRS.

Actemra is intended for use under the guidance of a healthcare practitioner.

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, including China, India, Brazil, Switzerland and Australia.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

SOURCE: Genentech

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