Sanofi’s Rezurock recommended for EU approval by the CHMP

The European Medicines Agency’s Committee for Medicinal Products for Human Use, CHMP, has adopted a positive opinion recommending the conditional marketing authorisation of Rezurock in the EU for the treatment of adults and in children aged 12 years and older with a body weight of at least 40 kg, with chronic graft-versus-host disease. The medicine is to be used when other treatment options provide limited clinical benefit, are not suitable, or have been exhausted. This positive recommendation comes after Sanofi (SNY) requested a re-examination of the prior negative opinion adopted by the CHMP in October 2025. The final European Commission decision is expected in the coming weeks.