Roche initiates Phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia

Basel, 19 March 2020- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced   we are working with the Food& Drug Administration (FDA) to initiate a randomised, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR), to evaluate the safety and efficacy of Actemra ®/RoActemra® (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. This is the first global study of Actemra/RoActemra 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 US. 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/RoActemra for the treatment of people hospitalised with COVID-19 pneumonia, so that we can better establish the potential role for Actemra/RoActemra in fighting this disease, " said Levi Garraway, M.D., Ph.D., Roche ’s 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...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news