CDSCO gives nod to Jardiance usage

As per the pharma company, the drug Jardiance (empagliflozin) 10mg tablets has been approved to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR) which is done to check how well the kidneys are filtering, end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease (CKD) at risk of progression. 

In 2022, the company had announced that it had received the CDSCO’s approval to market its innovator cardiac drug Jardiance (empagliflozin) in India. Earlier, the Jardiance was given approval only for the treatment of heart failure with reduced ejection fraction (HFrEF).

“This indication approval allows the nephrologists and cardiologists to use Jardiance 10mg tablets for the treatment of CKD in eligible patients,” it said in a statement.

The Germany based pharma company however noted that the drug 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 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,” the company noted in the statement.

Before the getting the nod, the company had also conducted a EMPA-KIDNEY phase III trial on 6,609 adults with CKD at risk of progression, across a broad range of underlying causes with and without diabetes, as well as different stages of CKD with and without albuminuria. The patients received either Jardiance 10 mg once daily or a placebo, on top of the current standard of care. Jardiance significantly reduced the relative risk of kidney disease progression or cardiovascular death in adults with CKD by 28% compared with placebo, both on top of standard of care.

“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,” said Gagandeep Singh Bedi, Managing Director, Boehringer Ingelheim India.

People with diabetes, high blood pressure, cardiovascular disease, and family history of kidney disease, are some individuals who have a high risk for developing chronic kidney disease. According to experts, it is essential that these individuals get regularly tested for chronic kidney disease and receive appropriate treatment for optimum kidney protection.

“The scientific evidence with empagliflozin, on providing clinically meaningful improvement in CKD outcomes across a broad range of eligible patients, provides compelling reasons to improve the current treatment landscape of CKD. 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,” added Dr. Shraddha Bhure, Medical Director, Boehringer Ingelheim India.

Milestone Alert!
Livemint tops charts as the fastest growing news website in the world 🌏 Click here to know more.

Unlock a world of Benefits! From insightful newsletters to real-time stock tracking, breaking news and a personalized newsfeed – it’s all here, just a click away! Login Now!

Published: 14 Feb 2024, 10:25 PM IST