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

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 ...

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

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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Sanofi has initiated a Phase 2a clinical study titled A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate th ...

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.