Sanofi (SNY,SAN.PA,SNYNF) announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has granted orphan drug designation to Rilzabrutinib for IgG4-related disease (IgG4-RD). The designation was backed by the positive data from a Phase 2 study of Rilzabrutinib in IgG4-RD.
IgG4-RD is a progressive, relapsing, chronic immune-mediated rare disease which can manifest in almost every organ and can lead to organ damage and irreversible dysfunction with fatal outcomes sometimes.IgG4-RD has an estimated prevalence of about eight cases per 100,000 adults in Japan.
Rilzabrutinib is an investigational, oral, reversible, BTK inhibitor. BTK, expressed in B cells, macrophages, and other innate immune cells, plays a critical role in inflammatory pathways and multiple immune-mediated disease processes.
In the study of IgG4-RD patients, treatment with Rilzabrutinib for 52 weeks reduced disease flares and other disease markers and minimised the need for glucocorticoid treatment. The safety profile of Rilzabrutinib in the study was consistent with previous studies in other indications, with no new safety signals observed, according to the firm.
In 2025, Rilzabrutinib received approval for the treatment of immune thrombocytopenia (ITP) in the US, the EU, and the UAE. Additionally, Rilzabrutinib is currently under regulatory review for ITP in Japan. Rilzabrutinib is being studied across many rare immune-mediated diseases like Chronic spontaneous urticaria, Asthma and more.
SNY has traded between $44.62 and $60.12. The stock closed Friday's trade at $48.66, up 0.64%.
SNY is down 2.38% at $47.50 in the overnight trade.
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