Sep 26, 2023
The U.S. Food and Drug Administration (FDA) has approved Jardiance® (empagliflozin) for the treatment of adults suffering from chronic kidney disease (CKD). With over 35 million adults in the U.S. affected by CKD, this approval could serve as a watershed moment for better, more efficient patient care. Here's an in-depth look at what this means for CKD patients and the healthcare industry.
The EMPA-KIDNEY phase III trial revealed that Jardiance significantly reduces the risk of kidney disease progression and cardiovascular death in adults with CKD. This trial makes EMPA-KIDNEY the first SGLT2 inhibitor CKD trial to show a statistically significant reduction in the risk of first and recurrent hospitalizations. Given that hospitalization costs often account for a considerable portion of healthcare expenses for CKD patients, these results hold substantial economic and clinical implications.
The FDA approval specifies that Jardiance can reduce the risk of various critical outcomes:
- Sustained decline in estimated glomerular filtration rate (eGFR)
- End-stage kidney disease
- Cardiovascular death
- Hospitalization for those with CKD at risk of progression
However, the drug is not recommended for type 1 diabetes patients and has limited efficacy in type 2 diabetes patients with an eGFR less than 30 mL/min/1.73 m^2. It is also not recommended for CKD patients with polycystic kidney disease or those who have recently undergone immunosuppressive therapy.
Hospitalizations often account for up to half of the total healthcare costs for CKD patients. The EMPA-KIDNEY trial demonstrated a 14% relative risk reduction in hospitalizations with Jardiance versus a placebo, indicating that the medication could offer cost-saving benefits for the healthcare system. Given its clinically demonstrated benefits, Jardiance provides a critical alternative for adult patients with CKD at risk of progression.
Jardiance's FDA approval comes on the heels of its recent approval for the same indication in the European Union. The drug has demonstrated robust results in clinical trials, with over 700,000 adults enrolled worldwide, reinforcing Boehringer Ingelheim and Eli Lilly's commitment to improving outcomes for people with cardio-renal-metabolic conditions.
The FDA approval of Jardiance is an essential milestone in CKD treatment. With its significant impact on reducing the risk of disease progression, cardiovascular death, and hospitalizations, Jardiance offers a lifeline for millions of adults suffering from this under-recognized public health crisis. As healthcare providers continue to seek effective and efficient treatment options, Jardiance's approval may indeed signify a new era in CKD management.
For healthcare professionals and patients alike, this approval is a beacon of hope and an affirmation of the relentless pursuit of better treatment alternatives. As we look to the future, Jardiance may well become a cornerstone in the battle against CKD, one of the most challenging healthcare problems of our times.
Rich Foreman brings over 30 years of technology leadership to his role of CEO and Co-Founder of KidneySoft. As founding CTO, Rich led the team that developed the CordicoShield / CordicoFire Wellness App. Cordico was honored with the Sacramento Innovation Award in 2021. After achieving a 7 digit ARR, Cordico was acquired by Lexipol in 2020. Rich has a BS in Industrial Engineering from the University of Washington, an MPA from Troy State University and was an officer in the U.S. Navy. Rich co-authored his book, "Tap into the Mobile Economy." Rich's blog was listed in Top 20 Marketing Mobile Blogs of 2014. He has been featured on KCRA3, NEWS10, 1170 Tech AM PowerDrive, Business Radio Money 105.5, SiliconIndia, the Sacramento Business Journal, and the Sacramento Bee. Rich is also the Founding Director of the Sacramento Chapter of Startup Grind and served a term as Utility Commissioner for the City of Folsom. Rich is a regular contributor to TechWire.net and StartupSac. Rich was the Co-founder of Apptology which was named Small Business of the Year in 2014 by the Sacramento Asian Pacific Chamber. He was also the Founding Chief Technology Officer at Cordico. Cordico was acquired by Lexipol in 2020. Rich also served 4 years as a Naval Officer in the Civil Engineer Corps.
This material is for informational purposes only. It does not replace the advice or counsel of a doctor or health care professional. KidneyLuv makes every effort to provide information that is accurate and timely, but makes no guarantee in this regard. You should consult with, and rely only on the advice of, your physician or health care professional.