Jardiance now approved in India for treatment of chronic kidney disease, ET HealthWorld

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Mumbai: The national regulatory authority of India, the Central Drugs Standard Control Organisation (CDSCO), has approved Jardiance (empagliflozin) 10mg tablets to reduce the risk of sustained decline in eGFR (only for patients with eGFR 30-90 ml/min/1.73m2), end-stage kidney disease, cardiovascular death, and hospitalisation in adults with chronic kidney disease (CKD) at risk of progression.

This indication approval allows the nephrologists and cardiologists to use Jardiance 10mg tablets for the treatment of CKD in eligible patients. It should be noted that Jardiance is not recommended for the treatment of CKD in patients with polycystic kidney disease, or patients requiring or with a recent history of intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease.

“Chronic kidney disease is an important health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” said Gagandeep Singh Bedi, Managing Director, Boehringer Ingelheim India. “We are very excited about the approval and the potential for empagliflozin to play an essential role in helping people living with kidney disease and their physicians.”

Dr Shraddha Bhure, Medical Director, Boehringer Ingelheim India, said, “CKD is a major health problem in India, arising from common risk factors like diabetes, hypertension, or cardiovascular disease, to name a few. Patients with CKD progression are at increased risk of hospital admissions, cardiac events, kidney failure, and death. Apart from the impact on health, a large proportion of patients with CKD also need to face catastrophic health expenditures. Optimum management of CKD can foster substantial improvements in the health and economic outcomes, for not only the patients and their families but also the society and the country’s healthcare system at large.”

  • Published On Feb 15, 2024 at 05:09 PM IST

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