Chugai files NDA in Japan for crovalimab for PNH

14 June 2023

Japanese drugmaker Chugai Pharmaceutical (TYO: 4519) said today it has filed a regulatory application with the Ministry of Health, Labor and Welfare (MHLW) for the anti-C5 antibody crovalimab for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

The application is based on the results of the COMMODORE 2 study in people with PNH not previously treated with C5 inhibitors and the COMMODORE 1 study in people with PNH who switched to crovalimab from currently approved C5 inhibitors.

Both are global Phase III clinical studies conducted in collaboration with Swiss pharm giant Roche (ROG: SIX), which is the majority shareholder of Chugai, with participation from Japan.

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