US FDA approves Jardiance® for the treatment of adults with chronic kidney disease

by Arjun Singh

Approval Adds to Treatment Options for Adults with Chronic Kidney Disease in the U.S.

Chronic kidney disease (CKD) affects more than 35 million adults in the U.S., making it a prevalent and serious health issue. However, there is promising news for those living with CKD as the U.S. Food and Drug Administration (FDA) has recently approved Jardiance® (empagliflozin) 10 mg tablets as a treatment option. Boehringer Ingelheim and Eli Lilly and Company announced that Jardiance has been approved to reduce the risk of kidney disease progression, end-stage kidney disease, cardiovascular death, and hospitalization in adults with CKD who are at risk of progression.

Jardiance is a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor, and it has already demonstrated its efficacy in reducing the risk of heart failure and improving glycemic control in patients with type 2 diabetes. Now, the approval of Jardiance for CKD offers a significant advancement in treatment options for this population.

The approval of Jardiance is based on the results of the EMPA-KIDNEY phase III trial, which demonstrated the drug’s ability to significantly reduce the risk of kidney disease progression and cardiovascular death. The trial included over 6,600 patients with CKD, both with and without type 2 diabetes, and showed that Jardiance led to a 28% relative risk reduction in the composite primary endpoint of kidney disease progression or cardiovascular death compared to placebo. Additionally, Jardiance also demonstrated a significant reduction in the risk of first and recurrent hospitalization, a pre-specified key secondary endpoint, with a 14% relative risk reduction compared to placebo.

Dr. Katherine Tuttle, a member of the EMPA-KIDNEY steering committee, expressed her enthusiasm about the approval, stating that it provides healthcare professionals in the U.S. with another treatment option that can effectively reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalizations in adults with CKD at risk of progression. She added that the benefits demonstrated by Jardiance are welcome news for adults living with CKD in the country.

Mohamed Eid, a vice president at Boehringer Ingelheim Pharmaceuticals, highlighted the significant impact of CKD on public health, stating that it remains an under-recognized crisis. He emphasized that hospitalizations account for a significant portion of healthcare costs for this population, and disease progression often leads to serious cardiovascular complications and kidney failure, which can require dialysis or transplantation. Therefore, the clinically demonstrated benefits of Jardiance offer a valuable treatment option for adults with CKD at risk for progression.

It is important to note that Jardiance is contraindicated in people with hypersensitivity to empagliflozin or any of the excipients in the medication. Therefore, patients should consult their healthcare providers before starting any new treatment.

The FDA approval of Jardiance for CKD marks a significant milestone in the treatment of this condition. With its proven efficacy in reducing the risk of kidney disease progression, cardiovascular death, and hospitalization, Jardiance provides healthcare professionals with a valuable tool to improve outcomes for people living with CKD in the U.S. This approval further strengthens the commitment of Boehringer Ingelheim and Eli Lilly and Company to support the cardio-renal-metabolic community worldwide.

In conclusion, the approval of Jardiance provides hope and additional treatment options for the millions of adults affected by chronic kidney disease in the U.S. Its demonstrated ability to reduce the risk of kidney disease progression, cardiovascular death, and hospitalization brings much-needed relief to this population. CKD is a serious public health crisis, and Jardiance offers a significant step forward in managing and improving outcomes for adults with CKD at risk for progression.

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