At a Glance
- Roche said it’s EMPACTA trial, introducing Actemra/Roacterma drug outshines the need for ventilators in the third face of clinical trials on COVID-19 patients associated pneumonia.
- The patients who received the drug were 44% less inclined towards using ventilators, compared to the patients who did receive mere standard care.
- The test was the first fruitful trial among minority patients.
- About 85% of the 389 patients were Hispanic, Native American, and Black.
Previously, Roche conducted a Covacta trial for the COVID-19 patients suffering Pneumonia. The trial did not show expected results, however, the EMPACTA trial is showing impact by far.
What is the EMPACTA trial?
EMPACTA trial (Evaluating Minority Patients with Actemra) is a Phase III, recombined, double-blind, placebo-controlled multicenter study associated with COVID 19 patients suffering from pneumonia. The trial registered hospitalized patients subjected to standard care and are in the age group of 18+, with confirmed SARS-CoV-2(COVID-19) with SpO2<94% (the patients who don’t require ventilators). There are two objectives regarding the trial;
- Primary endpoint: The cumulative proportion of patients dying or demanding ventilators by Day 28.
- Secondary endpoint: Time for clinical failure, mechanical ventilation, ICU admission, mortality rate by Day 28, and the Discharge day.
“The EMPACTA trial demonstrated that Actrema/RoActrema can reduce the need for mechanical ventilation in patients with COVID-19 associated pneumonia, an important outcome in the serious disease,” said Levi Garraway, Roche’s Chief Medical Officer.
Views on EMPACTA
EMPACTA trial is termed to be the first global phase III COVID-19 clinical trial choosing patients across minority racial and ethnic groups. “We have been striving to improve inclusion and diversity in our trials. During the COVID-19 pandemic, we saw how high the stakes were for many communities of color and made diversity the centerpiece of this trial,” said Jamie Freedman, M.D, Ph.D., Head of U.S Medical Affairs.
Actemra/RoActemra drugs are currently undergoing investigation as a capable treatment for COVID-19 associated pneumonia patients, while phase III REMDACTA clinical trial will follow. Both the drugs were the first approved anti-Il-6 receptor biologic available in both Intravenous (IV) and subcutaneous (SC) ways.
Final statement:
Roche further affirmed it would share the reports of its trial with health authorities, U.S Food and Drug Administration.
About the company
Roche is a global developer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. Uniting the strengths of pharmaceuticals and diagnostics on a single plateau has made them lead the line. They are strategized to fit the right treatment to each patient in the best way possible.
