Japan Approves Monoclonal Antibody Treatment

Japan-based Chugai Pharmaceutical Co., Ltd. announced on January 21, 2022, that it obtained regulatory approval from the Ministry of Health, Labour, and Welfare for the Actemra® humanized anti-human IL-6 receptor monoclonal antibody (mAbs).

Actemra has already obtained regulatory approval for various indications in more than 110 countries.

Japan's approval came one month after the application for the additional indication of Actemra Intravenous Infusion 80 mg, 200 mg, and 400 mg for the additional indication of the treatment of SARS-CoV-2 pneumonia, limited to patients requiring oxygen intervention.

"Clinical studies demonstrated that Actemra reduced the mortality rate in patients with SARS-CoV-2 infection," Chugai's President and CEO, Dr. Osamu Okuda, commented in a related press statement.

"We hope that Actemra will play a role for the better prognosis of patients with severe, potentially life-threatening pneumonia."

This COVID-19 treatment 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).

Actemra has been approved in the European Union, authorized for emergency use in the United States, and recommended by the World Health Organization to treat COVID-19.

Actemra is designed to block the activity of IL-6, a type of inflammatory cytokine. First launched in June 2005, the intravenous injection is approved for six indications in Japan: Castleman's disease, rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, cytokine release syndrome induced by tumor-specific T cell infusion therapy, and adult Still's disease.

In addition, Actemra subcutaneous injection is approved for three indications in Japan: rheumatoid arthritis, Takayasu arteritis, giant cell arteritis.