Roche says its rheumatoid arthritis drug reduces the need for ventilators in coronavirus patients
Roche says that its Actermra/Roactemra drugs reduce the likelihood that coronavirus patients with virus-related pneumonia will need to be put on a ventilator.
This is according to the company’s Empacta Phase 3 trial conducted in multiple countries including the US. It found that hospitalised patients taking the drug were 44% less likely to need ventilators or die. Roche intends to submit these results to the FDA.
Levi Garraway, Roche’s Chief Medical Officer and the Head of Global Product Development, commented on the results: “The Empacta trial demonstrated that Actemra/RoActemra can reduce the need for mechanical ventilation in patients with COVID-19 associated pneumonia, an important outcome in this serious disease.”
This study is also the first global Phase 3 trial that is specifically targeted at patients from minority racial and ethnic groups that are often underrepresented in clinical studies. The majority were Hispanic but it also included Black and Native Americans in the study population.
In a separate Phase 3 trial in July, the Actemra/RoActemra drug failed to meet the primary endpoint of improved clinical status in hospitalised adults with severe COVID-19-related pneumonia. The key secondary endpoints included the difference in patient mortality at week four but this was also not met. The data did show a positive trend in the time to hospital discharge.
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