Boehringer’s Jardiance gets CDSCO nod for chronic kidney disease

Feb 15,2024

Boehringer Ingelheim’s (BI) on Wednesday said its diabetes drug Jardiance (empagliflozin) 10mg dosage form has now been approved by the Central Drugs Standard Control Organisation of India for the treatment of chronic kidney disease (CKD), as an additional indication.

This indication approval allows the nephrologists and cardiologists to use Jardiance 10mg tablets for the treatment of CKD in eligible patients.

Jardiance in clinical trials has found to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR) (for patients with eGFR 30-90), end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease (CKD) at risk of progression.

The approval has the potential to advance the standard of care for an estimated more than 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, MD, 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,” Bedi said.

Source: Pharma