Drugmaker Sanofi Healthcare India has got the marketing authorization to sell its transplant-related drug Rezurock (Belumosudil tablets), in India.
The drug Rezurock represents a new treatment for cGVHD (chronic graft-versus-host disease) patients. (12 years and above), after failure of two previous lines of treatment, including those with difficult-to-treat manifestations like fibrosis, Sanofi said. cGVHD is a complication that can occur following allogeneic (from a donor) stem cell transplantation, resulting in significant morbidity and mortality, a note from Sanofi explained. “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,” it added.
Rezurock was approved by the regulatory United States Food and Drug Administration (in 2021), and India’s CDSCO (Central Drugs Standard Control Organisation) 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.
- Read also: ‘Give your body a break, a chance to reset’
Rodolfo Hrosz, Managing Director, Sanofi India, 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.”
Administered once daily (orally), Rezurock ( 200 mg) achieved an Overall Response Rate (ORR) of 74 percent and has shown robust and durable responses across the spectrum of cGVHD, Sanofi said. 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, it added.