Sanofi Healthcare India Pvt. Limited has received marketing authorization for Rezurock (Belumosudil Tablets) in India. This marks a significant advancement in the treatment of chronic graft-versus-host disease (cGVHD) for patients aged 12 and above who have not responded to at least two previous lines of therapy. Rezurock offers a new, best-in-class treatment option, particularly for those with fibrotic and difficult-to-treat manifestations of cGVHD.
Regulatory Approvals and Clinical Evidence
Rezurock received US FDA approval in 2021 and was subsequently approved by India’s CDSCO in 2024. The approval is based on results from ROCKstar, a randomized, open-label, multicenter pivotal trial that evaluated the safety and efficacy of Rezurock in patients with cGVHD who had received two to five prior systemic treatments.
High Efficacy and Favorable Safety Profile
Administered once daily as a 200 mg oral tablet, Rezurock demonstrated an Overall Response Rate (ORR) of 74%. It has shown robust and durable responses across various cGVHD manifestations. The safety profile of Rezurock aligns with the expected adverse events in patients undergoing treatment with corticosteroids and other immunosuppressants.
Addressing an Urgent Medical Need
As reported by medicaldialogues.in, Rodolfo Hrosz, Managing Director of Sanofi India Limited, emphasized the severe impact of cGVHD on patients’ daily lives and the limited treatment options available. He stated, “This milestone reflects our commitment to addressing unmet medical needs in the transplant ecosystem and delivering breakthrough therapies for patients with this severe condition. The introduction of Rezurock reinforces Sanofi India’s leadership in immunology and transplant care.”
Understanding Chronic Graft-Versus-Host Disease (cGVHD)
cGVHD is a serious complication of allogeneic stem cell transplantation that leads to significant morbidity and mortality. In this condition, transplanted immune cells (graft) attack the patient’s own cells (host), causing inflammation and fibrosis in multiple organs, including the skin, mouth, eyes, joints, liver, lungs, esophagus, and gastrointestinal tract.
Sanofi’s Commitment to Accessibility
Sanofi has pledged to work closely with healthcare professionals and stakeholders to ensure Rezurock reaches patients across India. The company remains dedicated to improving transplant care and expanding access to life-changing treatments for those suffering from cGVHD.