Roche Pharmaceutical Development and Sales Overview
Actemra/RoActemra (tocilizumab, RG1569)
Interleukin 6 receptor inhibitor
Indication
Phase/study
# of patients
Phase III
COVACTA¹
N=450
ARM A: Actemra plus standard of care
ARM B: Placebo plus standard of care
Design
Adult hospitalised with severe COVID-19 pneumonia
Primary endpoint
Status
■
Clinical status assessed using 7-Category Ordinal Scale (Day 28)
FPI Q1 2020
Recruitment completed Q2 2020
Primary endpoint not met Q3 2020
Published in NEJM 2021; 384:1503-1516
CT Identifier
NCT04320615
◉
Phase III
REMDACTA²
N=650
ARM A: Remdesivir plus Actemra
ARM B: Remdesivir plus placebo
■ Time to hospital discharge or ready for discharge
FPI Q2 2020
Recruitment completed Q1 2021
Primary endpoint not met Q1 2021
Published in Intensive Care Med 2021 doi: 10.1007/s00134-021-06507-x
Filed in EU Q3 2021
Approved in EU Q4 2021
Filed in US Q1 2022
1In collaboration with US Biomedical Advanced Research and Development Authority (BARDA); 2In collaboration with Gilead Sciences, Inc.
NEJM-New England Journal of Medicine
Roche
NCT04409262
93
ImmunologyView entire presentation