Actemra approved for additional indication of SARS-CoV-2 pneumonia in Japan- Chugai.
The approval came one month after the application for the additional indication on December 13, 2021. This approval is based on the results from clinical studies evaluating Actemra in hospitalized patients, including an investigator-initiated, randomized, open-label, platform overseas study (RECOVERY study), three placebo-controlled, randomized, double-blind, multicenter global phase III studies conducted by Roche (COVACTA study, EMPACTA study, REMDACTA study), and a single-arm, multicenter phase III study in Japan (J-COVACTA study) .
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