Sanofi India receives marketing authorisation for Rezurock in India
Belumosudil Tablets approved for chronic graft-versus-host disease treatment
Sanofi Healthcare India has received marketing authorisation for Rezurock (Belumosudil Tablets) in India. The treatment is indicated for patients aged 12 years and above with chronic graft-versus-host disease (cGVHD) who have not responded to at least two prior lines of therapy, including cases with fibrosis.
Rezurock was approved by the United States Food and Drug Administration (US FDA) in 2021 and by the Central Drugs Standard Control Organisation (CDSCO) in India in 2024. The approvals are based on safety and efficacy data from the ROCKstar trial, a randomised, open-label, multicentre pivotal study evaluating Rezurock in patients with cGVHD who had received two to five prior lines of systemic therapy.
Rezurock is administered orally once daily at a 200 mg dose. The trial reported an Overall Response Rate (ORR) of 74 per cent, demonstrating responses across the spectrum of cGVHD. The treatment has been observed to be safe and well-tolerated, with adverse events aligning with those expected in patients receiving corticosteroids and other immunosuppressants.
Rodolfo Hrosz, Managing Director, Sanofi India, stated, “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.”
Chronic graft-versus-host disease is a complication that can arise following allogeneic stem cell transplantation. It results in inflammation and fibrosis across multiple tissues, including the skin, mouth, eyes, joints, liver, lungs, oesophagus, and gastrointestinal tract. The condition contributes to significant morbidity and mortality among affected patients.
Sanofi India has stated its commitment to working with healthcare professionals and stakeholders to ensure that Rezurock is accessible to patients across India.