Jardiance Gets CDSCO Approval for Chronic Kidney Disease

  • 17 Feb 2024

Drug manufacturing company Boehringer Ingelheim's drug, Jardiance, recently received approval from India's drug regulator, Central Drugs Standard Control Organisation (CDSCO), for treating chronic kidney disease (CKD), expanding its indications beyond Type 2 diabetes.

Key Points

  • Expanded Indication: Jardiance 10mg tablets approved for CKD treatment in eligible patients by nephrologists and cardiologists.
  • Scope of Approval: CDSCO approves Jardiance to reduce risk of eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization in adults with CKD at risk of progression.
  • Limitations: Not recommended for CKD treatment in patients with polycystic kidney disease or those requiring or with recent history of specific therapies.
  • Impact on Healthcare: Approval expected to benefit an estimated 33 million adults in India with CKD, reducing hospitalizations and delaying kidney failure progression.
  • Medical Perspective: CKD poses a major health concern in India due to risk factors like diabetes and hypertension. CKD progression increases risks of hospitalizations, cardiac events, and mortality.