CHMP Rejects Sanofi’s Rezurock Over Clinical Data Issues, Recommends Approval of BTK Inhibitor Wayrilz

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion on Sanofi’s Rezurock (belumosudil) for the third-line treatment of adults and pediatric patients with chronic graft-versus-host disease (cGVHD), citing concerns over clinical data1 11 13.

Sanofi has stated its intention to seek a re-examination of the Rezurock application, emphasizing confidence in the therapy’s clinical and real-world evidence and its established safety profile1 11 13.

Rezurock is already approved for cGVHD in the US, UK, Canada, China, and other countries, and has been prescribed to over 17,000 patients since its first approval in July 202111.

Conversely, the CHMP has adopted a positive opinion recommending EU approval of Sanofi’s Wayrilz (rilzabrutinib), a Bruton's tyrosine kinase (BTK) inhibitor, for adults with immune thrombocytopenia (ITP) who are refractory to other treatments2 4 6 11.

Wayrilz’s recommendation is based on data from the pivotal LUNA 3 phase 3 study, which showed rapid, durable platelet responses and significant improvements in bleeding and quality of life measures for ITP patients2 4 6 10 11.

If approved, Wayrilz will be the first BTK inhibitor available for ITP in the EU, marking a new immunological treatment approach that targets the root cause of the disease via multi-immune modulation2 6 10.

A final European Commission decision on Wayrilz approval is expected in the coming months2 6.