(RTTNews) - Roche's (RHHBY) phase III study, which evaluated Actemra plus standard of care in patients with COVID-19 pneumonia, dubbed EMPACTA, has met the primary endpoint, demonstrating a reduced need for mechanical ventilation by day 28.
According to the trial results, patients with COVID-19 associated pneumonia who received Actemra plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care. The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra arm versus 19.3% in the placebo arm.
However, there was no statistical difference in mortality between patients in the Actemra arm versus the placebo arm.
Actemra is an approved drug for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, and CAR T cell-induced severe or life-threatening cytokine release syndrome.
Commenting on the trial results, Levi Garraway, chief medical officer and head of Global Product Development, said, "The EMPACTA trial demonstrated that Actemra can reduce the need for mechanical ventilation in patients with COVID-19 pneumonia, an important outcome in this serious disease. We plan to share this important data with the FDA and other health authorities around the world."
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