BRIEF—Actemra cleared for SARS-CoV-2 pneumonia in Japan

Japanese drugmaker Chugai Pharmaceuticals has obtained regulatory approval from the Ministry of Health, Labor and Welfare for the humanized anti-human interleukin (IL)-6 receptor monoclonal antibody Actemra (tocilizumab; genetical recombination) for the additional indication of the treatment of SARS-CoV-2 pneumonia (limited to patients requiring oxygen intervention).

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 Chugai’s majority owner Roche (COVACTA study, EMPACTA study, REMDACTA study), and a single-arm, multicenter Phase III study in Japan (J-COVACTA study).

Actemra has been approved in the European Union, is authorized for emergency use in the USA, and recommended by the World Health Organization for the treatment of COVID-19.