By Fineline Cube 
Sanofi (NASDAQ: SNY) announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Rezurock (belumosudil) in patients aged 12 and above, weighing at least 40kg, with chronic graft‑versus‑host disease (cGVHD) who have limited clinical benefit from, are ineligible for, or have exhausted other prior treatment options.
Regulatory Milestone & Drug Status
| Item | Detail |
|---|---|
| Company | Sanofi (NASDAQ: SNY) |
| Drug | Rezurock (belumosudil) |
| Mechanism | First‑in‑class selective ROCK2 inhibitor |
| Recommended Indication | cGVHD in patients ≥12 years, ≥40kg |
| Regulatory Body | EMA CHMP |
| Global Registration | 20 countries including US, UK, Canada |
| US Indication | Failed ≥2 lines of therapy |
| China Indication | Failed first‑line systemic therapy |
| Expansion Plans | Exploring use in patients >1 year old and chronic lung allograft dysfunction |
Market Impact & Commercial Outlook
- cGVHD Market: EU market valued at $500 million : in 2025, growing at 8% CAGR : post‑transplant
- Patient Population: ~30% of allogeneic stem cell transplant recipients develop cGVHD; limited options for refractory patients
- Competitive Landscape: Competes with ibrutinib, ruxolitinib; Rezurock’s ROCK2 inhibition offers novel mechanism
- Revenue Potential: Analysts project €200–350 million : peak annual EU sales by 2028; global franchise could exceed $600 million :
- Strategic Value: Strengthens Sanofi’s transplant/oncology supportive care portfolio; validates ROCK2 platform for expansion
- Next Steps: European Commission decision expected Q2 2026; potential US FDA filing for expanded age range under evaluation
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory approvals, market penetration, and revenue projections for Rezurock. Actual results may differ due to EC decision timelines, competitive dynamics, and market access negotiations.-Fineline Info & Tech