Roche provides update on the phase III REMDACTA trial of Actemra/RoActemra plus Veklury in patients with severe COVID-19 pneumonia

Basel, 11 March 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the global phase III randomised, double-blind, multicentre REMDACTA study of Actemra®/RoActemra® (tocilizumab) plus Veklury® (remdesivir), versus placebo plus Veklury, did not meet its primary endpoint. This was measured by improved time to hospital discharge up to day 28 in patients with severe COVID-19 pneumonia receiving standard of care. No new safety signals were identified for Actemra/RoActemra in the REMDACTA trial. The study was conducted in collaboration with Gilead Sciences, Inc.

Roche will continue to evaluate data from the REMDACTA, COVACTA and EMPACTA studies as well as other studies of Actemra/RoActemra in COVID-19 pneumonia. The EMPACTA study met its primary endpoint, while COVACTA did not meet its primary endpoint. Both were recently published in the New England Journal of Medicine.

“Given the global impact of COVID-19 pneumonia on patients, we are disappointed that the REMDACTA study did not meet its endpoints,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “We continue to believe that the totality of data suggests a potential role for Actemra in treating certain patients with COVID-19, and will discuss the results with health authorities. We thank our partners at Gilead, and all the patients, investigators and healthcare professionals for their participation.”

REMDACTA did not meet key secondary endpoints, which included likelihood of death, likelihood of progression to mechanical ventilation or death, and clinical status. The full results of the trial will be submitted for publication in a peer-reviewed journal later this year.

Actemra/RoActemra is not approved for the treatment of COVID-19 pneumonia.

The antiviral medication Veklury was invented and developed by Gilead Sciences and is approved or authorized for temporary use for the treatment of COVID-19 in approximately 50 countries worldwide.

For more information on how Roche is responding to the global COVID-19 pandemic, please visit our COVID-19 response page.