Roche nabs first global approval for self-injected PNH treatment
2024-02-08
上市批准临床3期临床结果
Roche’s crovalimab gained its first approval anywhere in the world with clearance in China for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). The authorisation, announced Thursday by partner Chugai, allows patients to administer the anti-C5 recycling monoclonal antibody at home by subcutaneous self-injection every four weeks.
The approval was based on results from a number of Phase III studies, including COMMODORE 3, which was conducted in China, and the global COMMODORE 2 trial. The therapy utilises Chugai’s recycling antibody technology, allowing crovalimab to bind to the C5 antigen repeatedly, enabling sustained complement inhibition at a low dose.
Regulatory applications for crovalimab are also under review in the US, Europe and Japan.
More to come.
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