French drug major Sanofi S.A. (SNYNF,SNY) announced that the Ministry of Health, Labour and Welfare in Japan has granted orphan drug designation to riliprubart, a monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway for people with chronic inflammatory demyelinating polyneuropathy or CIDP.
Despite current therapies, many patients with CIDP continue to experience residual symptoms—such as weakness, numbness, and fatigue—that contribute to long-term morbidity and reduced quality of life. Notably, approximately 30% of patients do not respond to standard treatment, Sanofi said.
The company noted that the decision by Japan's Ministry of Health, Labour and Welfare joins similar designations in the US and Europe, highlighting global regulatory recognition of riliprubart's potential to address critical unmet needs in treating this rare neurological condition.
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