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Sanofi
NEWS

Sanofi’s Rilzabrutinib Secures the EMA’s Orphan Drug Designation to Treat IgG4-Related Disease

Shots:The EMA has granted ODD to rilzabrutinib for the treatment of IgG4-related disease (IgG4-RD)Rilzabrutinib (PO) is being evaluated in a P-II trial for IgG4-RD with glucocorticoids vs glucocorticoids alone, showing reduced flares, improved disease markers, & steroid sparing over 52 weeks; data presented at EULAR 2025Rilzabrutinib, a reversible covalent BTK inhibitor, is…
August 14, 2025

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NEWS

Sobi Reports the US FDA’s Approval of Doptelet (Avatrombopag) to Treat Pediatric Immune Thrombocytopenia

Shots:The US FDA has approved Doptelet to treat thrombocytopenia in pts (≥1yrs.) with persistent or chronic ITP who have not responded to prior treatments. Approval also incl. a new formulation, Doptelet Sprinkle (avatrombopag) oral granules, for children (1-6yrs.)Approval was based on P-III (AVA-PED-301) study assessing Doptelet in pediatric ITP pts, which showed that…
July 28, 2025

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