Press Release: Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines
Sanofi - American Depositary Shares (SNY)
US:NYSE Investor Relations:
sanofi.com/en/investors
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Source: GlobeNewswire
Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines Designation granted for warm autoimmune hemolytic anemia and IgG4-related diseaseRilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia Paris, April 3, 2025. The US Food and Drug Administration (FDA) has granted orphan drug designation to rilzabrutinib, an investigational, novel, advanced, oral, reversible Bruton’s tyrosine kinase (BTK) inhibitor, for two rare diseases, warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD). There is still a significant unmet medical need for these two rare diseases, and neither have any currently approved medicine. FDA grants orphan drug designation to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the US. Karin Knobe, MD, PhDGlobal Head of Development, Rare Diseases“Orphan drug designation fo
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