Sanofi received a conditional marketing authorisation for Rezurock (belumosudil) to treat chronic graft‑versus‑host disease (GVHD) in adults and children 12 years and older, expanding the drug’s EU indication beyond its existing 20‑country approval.
The conditional authorisation is granted under the European Union’s conditional marketing authorisation framework, which allows early access to medicines that address unmet medical needs while requiring a confirmatory, randomised, controlled study to confirm the benefit‑risk profile. The approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use issued on January 30 2026.
The decision is based on data from the ROCKstar phase 2 study, which reported a 74% overall response rate in patients who had failed at least two prior lines of systemic therapy. The study also showed durable responses and a manageable safety profile, supporting the drug’s benefit‑risk balance.
Rezurock is a selective ROCK2 inhibitor that downregulates immune responses and may block fibrosis, addressing a key pathogenic mechanism in chronic GVHD. The drug was first approved in the United States in July 2021 and received orphan drug designation in 2019. Sanofi acquired the developer, Kadmon, in 2021, integrating Rezurock into its immunology portfolio.
Chronic GVHD affects up to 50% of patients who undergo allogeneic stem cell transplantation, creating a significant unmet medical need. The conditional approval is expected to broaden access to a therapy that offers meaningful clinical benefit for patients with limited options after multiple prior treatments.
Sanofi’s interim CEO Olivier Charmeil said, “We have an ongoing commitment to supporting patients with chronic GVHD and their caregivers and are pleased to deliver this new treatment option to patients living with this debilitating and long‑term condition.” He added that nearly one in two patients with chronic GVHD require third‑line treatment, underscoring the importance of new therapeutic options.
Medical expert Mohamad Mohty, Professor of Haematology, noted, “This approval represents an important advance, offering a new therapeutic option that has the potential to meaningfully improve the lives of patients.” The conditional approval is a milestone for Sanofi’s immunology strategy and is expected to contribute to the company’s overall growth trajectory, following a 9.9% increase in 2025 sales to €43.6 billion.
While the conditional authorisation allows Sanofi to market Rezurock in the EU, the company must complete the confirmatory trial to maintain the licence. The approval is a strategic win that positions Sanofi to capture a growing market for chronic GVHD therapies and strengthens its portfolio in a high‑need therapeutic area.
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