French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Tuesday that the European Commission has granted conditional marketing authorisation for Rezurock (belumosudil) to treat chronic graft-versus-host disease (GVHD) in patients aged 12 and older weighing at least 40 kg.

The therapy is indicated for patients with limited treatment options, including those where prior therapies have failed or are unsuitable. This approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued on 30 January 2026.

The decision is supported by clinical and real-world evidence, including results from the ROCKstar phase 2 study, which demonstrated durable and clinically meaningful responses in heavily pretreated patients. Under the conditional approval, Sanofi is required to complete a confirmatory randomised controlled trial.

Rezurock has orphan designation in the EU and is already approved in 20 countries, including the United States, United Kingdom, and Canada. More than 20,000 patients have been treated with the therapy since its initial US approval in July 2021, supporting its role in addressing unmet medical needs in chronic GVHD.