Sanofi’s Innovative Treatment Rezurock Gains Approval in India for Chronic Graft-Versus-Host Disease (cGVHD)
Sanofi Healthcare India Pvt. Limited has received marketing authorization for Rezurock (belumosudil Tablets) in India, offering a novel treatment option for patients suffering from chronic graft-versus-host disease (cGVHD). This severe and potentially life-threatening condition affects approximately 35-40% of individuals following a bone marrow transplant.
Rezurock introduces a groundbreaking treatment approach for cGVHD patients aged 12 years and older who have not responded to at least two prior lines of therapy. It is particularly beneficial for those with challenging symptoms such as fibrosis.
The therapy was initially approved by the US FDA in 2021 and subsequently received authorization from the Central Drugs Standard Control Organization (CDSCO) in India in 2024. Approval was based on data from the ROCKstar trial, a pivotal, multicenter, open-label, randomized study assessing the drug’s safety and effectiveness in cGVHD patients who had undergone two to five previous systemic treatments.
Taken orally once a day at a dosage of 200 mg, Rezurock demonstrated an impressive Overall Response Rate (ORR) of 74%, delivering sustained and meaningful improvements across a wide range of cGVHD symptoms.
The medication has been shown to be well-tolerated, with side effects consistent with those typically seen in patients receiving corticosteroids or other immunosuppressants for advanced cGVHD.
cGVHD is a serious complication arising from allogeneic stem cell transplants, where the donor’s immune cells attack the recipient’s tissues. This condition leads to inflammation and fibrosis across multiple organs, including the skin, mouth, eyes, joints, liver, lungs, esophagus, and gastrointestinal tract.
Sanofi is dedicated to working alongside healthcare providers and stakeholders to ensure Rezurock reaches patients across India, improving access to this critical treatment option.
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