The Central Drugs Standard Control Organisation (CDSCO) has approved Boehringer Ingelheim’s anti-diabetic drug for the treatment of chronic kidney disease (CKD) in India.
According to the company’s statement, Jardiance (empagliflozin) 10mg tablets have been approved 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 company said in a statement.
The approval has the potential to advance the standard of care for an estimated over 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.”
Chronic kidney disease (CKD) is a major health problem in India, with an alarming rise in recent years, and being amongst the top 10 causes of death in our country.
“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. The prognosis of CKD may vary according to different underlying causes and/or stages of CKD; this may necessitate proven treatment options for different patients with CKD. 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,” Dr. Shraddha Bhure, Medical Director, Boehringer Ingelheim India, said in a statement.
Progression of CKD increases the risk of cardiovascular death by 2-3 times, apart from leading to a higher risk of hospitalizations, and possible kidney failure. According to the company, Jardiance (empagliflozin) 10mg tablets significantly reduced the risk of kidney disease progression and cardiovascular death in eligible patients with CKD, as established in the EMPA-KIDNEY phase III trial.
