Sanofi secures approval in India for chronic graft-versus-host disease drug Rezurock
Sanofi Healthcare India Pvt. Limited has announced receipt of marketing authorization for Rezurock (Belumosudil Tablets) in India. Rezurock represents a new, best-in-class treatment paradigm for thousands of chronic graft-versus-host disease (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 (in 2021) and by the CDSCO 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) 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 said, “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.”
cGVHD is a complication that can occur following allogeneic stem cell transplantation, resulting in significant morbidity and mortality. In cGVHD, transplanted immune cells (graft) attack the patient's cells (host), leading to inflammation and fibrosis in multiple tissues, including skin, mouth, eye, joints, liver, lung, esophagus and gastrointestinal tract.
"Sanofi remains committed to collaborating with healthcare professionals and stakeholders to ensure Rezurock is accessible to patients across India," the Company stated in a release.
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