Press Release: Sanofi’s rilzabrutinib earns orphan drug designation in Japan for IgG4-related disease
Sanofi - American Depositary Shares (SNY)
US:NYSE Investor Relations:
sanofi.com/en/investors
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Source: GlobeNewswire
Sanofi’s rilzabrutinib earns orphan drug designation in Japan for IgG4-related disease Designation based on positive data from a phase 2 study of rilzabrutinib in IgG4-RDThird global orphan drug designation for rilzabrutinib in IgG4-RD, underpinning Sanofi’s commitment to rare immune-mediated diseases Paris, March 2, 2026 – The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted orphan drug designation to rilzabrutinib, a novel, oral, reversible covalent Bruton’s tyrosine kinase (BTK) inhibitor, for IgG4-related disease (IgG4-RD). There is still unmet medical need and limited treatment options in Japan for IgG4-RD, a rare, progressive, immune-mediated chronic condition in which the immune system attacks various tissues and organs leading to serious damage. The MHLW grants orphan designation to medicines that address rare diseases or conditions with unmet medical needs. Rilzabrutinib for the treatment of IgG4-RD was evaluated in a phase 2 study (clinical study identi
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