Sanofi India's Breakthrough Approval for cGVHD Treatment

Sanofi Healthcare India has received marketing authorization for Rezurock, a drug for chronic graft versus host disease (cGVHD). Approved by USFDA and CDSCO, Rezurock offers a new treatment for patients aged 12 and above after two failed treatment lines, addressing complex conditions like fibrosis.

Sanofi Healthcare India has announced a significant milestone as it secured marketing authorization for Rezurock, a drug targeted at treating chronic graft versus host disease (cGVHD). This development marks a new treatment avenue for global patients.

Rezurock, or Belumosudil tablets, received approval from major regulatory bodies including the US Food and Drug Administration (USFDA) and the Central Drugs Standard Control Organization (CDSCO) in India in 2024. It is intended for patients aged 12 and above who have not responded to at least two prior lines of therapy, especially those facing challenging conditions such as fibrosis.

Rodolfo Hrosz, Managing Director of Sanofi India, emphasized the company's commitment to addressing unmet medical needs in the transplant field with innovative therapies for severe conditions like cGVHD. This complication originates from allogeneic stem cell transplantation, leading to serious health issues.