Roche Accelerates Phase III Actemra Trial in COVID-19
By Contract Pharma Staff | 04.08.20
Receives $25 million in support from BARDA to evaluate safety and efficacy in severe COVID-19 pneumonia
Roche will accelerate Actemra's Phase III trial in COVID-19 patients with $25 million in support from the U.S. Biomedical Advanced Research and Development Authority (BARDA).
Actemra/RoActemra (tocilizumab), an anti-IL-6 receptor biologic currently approved to treat rheumatoid arthritis, is being evaluated in a randomized, double-blind, placebo-controlled Phase III trial in collaboration with BARDA, for safety and efficacy in hospitalized 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 with a target of approximately 330 patients globally, including the U.S. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables.