Roche Pharmaceutical Development and Sales Overview
Actemra/RoActemra (tocilizumab, RG1569)
Interleukin 6 receptor inhibitor
Indication
Phase/study
# of patients
Design
Primary endpoint
Status
CT Identifier
"
"
Adult hospitalised with severe COVID-19 pneumonia
Phase II
MARIPOSA
N=100
ARM A: 8 mg/kg Actemra plus standard of care
ARM B: 4mg/kg Actemra plus standard of care
Phase III
EMPACTA
N=379
Conducted in sites known to provide critical care to underserved and
minority populations that often do not have access to clinical trials
ARM A: Actemra plus standard of care
ARM B: Placebo plus standard of care
Pharmacodynamics and pharmacokinetics
FPI Q2 2020
Recruitment completed Q2 2020
Published in Open Forum Infect Dis 2021 Dec 4;9(1)
NEJM-New England Journal of Medicine
NCT04363736
Roche
Cumulative proportion of participants requiring mechanical ventilation
by day 28
"
FPI Q2 2020
Primary endpoint met Q3 2020
Published in NEJM 2021 Jan 7;384(1):20-30
Filed in EU Q3 2021
Approved in EU Q4 2021
Filed in US Q1 2022
NCT04372186
94
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ImmunologyView entire presentation