Sanofi Clinches Key Phase III Immunology Win With Rilzabrutinib

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Sanofi’s BTK inhibitor – one of two from its 2021 Principia buy – passed a Phase III test in immune thrombocytopenia as the company focuses on Dupixent-like blockbusters going forward.

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Sanofi may have the first BTK inhibitor approved for ITP • Source: Shutterstock

Sanofi, in the midst of recasting itself as an immunology-focused firm, revealed a successful topline Phase III readout in immune thrombocytopenia (ITP) on 23 April for its BTK inhibitor rilzabrutinib. The asset is one of 12 drugs and vaccines forecast to deliver up to €5bn each in peak sales, with several candidates – including rilzabrutinib – expected to offer pipeline-in-a-product potential, like the company’s Regeneron Pharmaceuticals, Inc.-partnered Dupixent (dupilumab).

Key Takeaways

  • Sanofi’s BTK inhibitor rilzabrutinib succeeded in a Phase III study in adults with immune thrombocytopenia (ITP); the company plans to report Phase II and IIb data in additional immunology indications later this year.

Rilzabrutinib is one of two BTK inhibitors Sanofi acquired in its $3.7bn purchase of Principia Biopharma, Inc. in 2020,...

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