MHLW approval for Piasky 340 mg for paroxysmal nocturnal hemoglobinuria in Japan.- Chugai/Roche
Chugai Pharmaceutical Co., Ltd. announced that it has obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for Piasky for Injection 340 mg (generic name: crovalimab (genetical recombination)) (hereafter, Piasky) , a pH-dependent binding humanized anti-complement (C5) monoclonal antibody for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
Piasky was approved in China in February this year for the treatment of adults and adolescents (12 years of age and above) with PNH who have not been previously treated with complement inhibitors. Japan is the first country in the world to obtain approval without restrictions on switching from existing C5 inhibitors, and without restrictions of age in patients over body weight of 40kg. It is currently under review for PNH by other regulatory authorities, including in the United States, Europe, and Taiwan.
This approval was based mainly on the results of the COMMODORE 2 study in patients with PNH who were naïve to C5 inhibitors and the COMMODORE 1 study in patients with PNH who switched to crovalimab from previously approved C5 inhibitors. Both are global phase III studies in collaboration with Roche, and Japan is also participating.
Piasky uses Chugai’s Recycling Antibody technology. Unlike conventional antibodies that bind to an antigen only once, crovalimab has been engineered to bind to the antigen repeatedly, enabling low dose subcutaneous administration every four weeks. This is the second approval for a drug using the recycling antibody technology following Enspryng for the treatment of neuromyelitis optica spectrum disorder (NMOSD).
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