Pharma Focus Asia

Chugai Pharmaceutical Submits a New Drug Application for Crovalimab in Japan

Thursday, June 15, 2023

Chugai Pharmaceutical has filed regulatory applications with the Ministry of Health, Labour and Welfare in Japan for the anti-C5 antibody called crovalimab.

Crovalimab has been developed using Chugai's Recycling Antibody® technology, which allows the antibody to bind to the target antigen repeatedly. This unique property enables sustained complement inhibition at a low dose, and the drug can be administered subcutaneously every four weeks.

Anti-C5 inhibitors are considered the standard of care for PNH, and Chugai aims to offer a new treatment option with subcutaneous crovalimab. 

The application is based on the clinical trials, including the COMMODORE 1 study for patients who switched from currently approved C5 inhibitors and the COMMODORE 2 study for patients not previously treated with C5 inhibitors, formed the basis of the regulatory application. These trials demonstrated favourable efficacy and safety of crovalimab, potentially reducing the treatment burden for patients by requiring less frequent dosing.

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