CDSCO approves Jardiance for treatment of adults with chronic kidney disease in India
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 hospitalization 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.
The approval has the potential to advance the standard of care for an estimated >33 million adults in India living with CKD and help relieve the burden on healthcare systems by reducing the risk of hospitalizations, as well as delaying progression to kidney failure, for people with CKD.
“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. It also underscores our commitment to bringing innovative solutions that address the unmet medical needs in India.”
Read also: Eli Lilly-Boehringer Ingelheim Jardiance gets USFDA approval for adults with chronic kidney disease
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