cGVHD is a life-threatening complication that can occur in 35-40% patients after bone marrow transplant[i]
India, February 10, 2025. Sanofi Healthcare India Pvt. Limited announces receipt of marketing authorization for Rezurock® (Belumosudil Tablets) in India.
Rezurock® represents a new, best-in-class treatment paradigm for thousands of cGVHD patients globally (12 years and above), after failure of two previous lines of treatment, including those with difficult-to-treat manifestations like fibrosis.
Rezurock® was approved by the US FDA[ii] (in 2021) and by the CDSCO[iii] in India (in 2024) based on safety and efficacy results from ROCKstar – a randomized, open-label, multicenter pivotal trial of Rezurock® in patients with cGVHD who had received two to five prior lines of systemic therapy.
Administered once daily (orally), Rezurock® 200 mg achieved an Overall Response Rate (ORR)[iv] of 74% and has shown robust and durable responses across the spectrum of cGVHD. It is safe and well-tolerated with adverse events being consistent to those expected in patients with advanced cGVHD receiving corticosteroids and/or other immunosuppressants.
Rodolfo Hrosz
Managing Director, Sanofi India Limited
“cGVHD has a debilitating impact on the day-to-day functioning of those suffering from it. Treatment options for people suffering from it are very limited. This milestone reflects our dedication 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 the field of immunology and transplant care.”
Corporate Comm India (CCI Newswire)
