Sanofi's Wayrilz Gets European Approval for Immune Thrombocytopenia

The European Commission has approved Sanofi’s Wayrilz (rilzabrutinib), a new (novel) oral Bruton’s tyrosine kinase (BTK) inhibitor, as an additional treatment for patients with Immune Thrombocytopenia (ITP) in the EU, in those who are refractory to previous treatments. Notably, this announcement follows the positive opinion of the CHMP in Europe.

Wayrilz has multiple immune modulatory effects; it acts on multiple mechanisms to increase platelet levels and resolve the associated symptoms of ITP, like tiredness and mental impairment. This approval has been driven by the data generated from the LUNA 3 Phase 3 study.

Patients receiving treatment with Wayrilz experienced a 10.6-point greater improvement on the ITP-Patient-Assessment-Questionnaire compared to the 2.3-point increase seen with the placebo.

Already approved in the US and UAE, Wayrilz has entered the regulatory approval phase in Japan and China, with orphan and fast-track approvals in various geographies. Apart from ITP, Wayrilz has trials for rare diseases such as wAIHA, IgG4-related diseases, and Sickle cell diseases.

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Sanofi also pointed out the differentiated approach offered by Wayrilz to patients with ITP. This is because instead of simply treating the Platelets, the drug targets the fundamental pathology.

This new development in the EU is a demonstration of Sanofi's ongoing commitment to offering patients with rare immune system diseases improved treatments.