Sanofi Healthcare Secures Marketing Authorization for Rezurock

Sanofi Healthcare India has received marketing authorization for Rezurock (belumosudil tablets) in India for the treatment of chronic Graft-versus-host disease (cGVHD) in patients aged 12 years and above. 

Rezurock is used globally for cGVHD patients who have failed at least two prior lines of treatment, including those with fibrotic complications. Graft-versus-host disease (GVHD) occurs when donor cells attack the recipient’s healthy cells post-bone marrow transplantation. 

Rezurock was approved by the USFDA in 2021 and received approval from India’s CDSCO in 2024 based on the ROCKstar trial, a randomized, open-label, multicenter pivotal study assessing its safety and efficacy in cGVHD patients who had undergone two to five prior systemic therapies. 

Key highlights of Rezurock: 

1. Administered once daily (200 mg, orally) 
2. 74% overall response rate (ORR) 
3. Effective across the cGVHD spectrum 
4. Safe and well-tolerated, with adverse effects comparable to corticosteroids and immunosuppressants

Sanofi India’s Managing Director Rodolfo Hrosz emphasized the limited treatment options for cGVHD and highlighted that Rezurock’s approval strengthens Sanofi India’s leadership in immunology and transplant care.