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Boehringer Ingelheim’s (BI) Jardiance (empagliflozin) has now been approved by the Central Drugs Standard Control Organisation —India’s drug regulator — for the treatment of chronic kidney disease (CKD), as an additional indication.
The approval allows nephrologists and cardiologists to use Jardiance 10mg tablets for the treatment of CKD in eligible patients, the company said. The drug was originally approved for the treatment of Type 2 diabetes, and over the last few months, it has been getting approval in other countries as well, for CKD.
Announcing the approval, BI said, “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 at risk of progression.”
Further, it added, Jardiance was 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 hospitalisations, as well as delaying progression to kidney failure, for people with CKD,” the company said.
“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, BI’s Managing Director, in a statement. Dr Shraddha Bhure, BI Medical Director added that CKD was a major health problem in India, arising from risk factors like diabetes, hypertension or cardiovascular disease, among others. “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,” she added.
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