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.
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