Sanofi wins EMA's orphan drug status for rilzabrutinib to treat IgG4-RD, a chronic, immune-mediated rare disease.

Paris: Sanofi has announced that the European Medicines Agency has granted orphan designation to rilzabrutinib, a reversible ...

Sanofi’s rilzabrutinib earns orphan designation in the EU for IgG4-related disease Data from the positive Phase 2 study evaluating rilzabrutinib for the treatment of IgG4-related disease presented at ...

EMA grants orphan designation to Sanofi’s rilzabrutinib, a reversible covalent BTK inhibitor, for IgG4-related disease: Paris Saturday, August 16, 2025, 09:00 Hrs [IST] Sanofi a ...

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Arguably the FDA’s most anticipated decision this month is for a subcutaneous induction formulation of Biogen and Eisai’s ...

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Novartis' mAb ianalumab helped maintain safe platelet levels for a prolonged period, reducing patient reliance on hospital ...

Currently, inebilizumab is being investigated in Phase III clinical trials for its potential use in treating IgG4-Related Disease. Rilzabrutinib: Sanofi ...

Similarly, Sanofi's rilzabrutinib, an oral BTK inhibitor, is gaining attention for its favorable safety profile and potential to offer durable responses in both newly diagnosed and relapsed patients.

Physicians highlighted a strong interest in several late-stage pipeline therapies, including nipocalimab (Johnson & Johnson), rilzabrutinib (Sanofi), and ianalumab (Novartis), with each seen as ...