Chronic kidney disease (CKD) is a condition where, over time, the kidneys become damaged, leaving them unable to filter waste and excess fluid. 37 million Americans are affected by CKD, and this number continues to grow worldwide.
Kidney disease is not a death sentence, but major lifestyle changes must be made to keep the condition under control. What’s more, there aren’t currently any medications approved specifically for kidney disease. Instead, patients typically take drugs to treat kidney disease-related complications like high cholesterol or high blood pressure.
But in recent years, developments have been made in the field of nephrology medications that should excite CKD sufferers worldwide. Here are some of the latest treatments for kidney disease, including currently unreleased experimental drugs and recent FDA approvals.
In late 2019, the FDA approved the first drug in 20 years to treat diabetic kidney disease. Previously used exclusively in type 2 diabetes treatment, the drug, called Invokana, can reduce risk of end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with both type 2 diabetes and diabetic kidney disease as well as slow the progression of kidney failure.
GCS-100 (La Jolla)
An experimental kidney disease drug called GCS-100 has shown statistically significant results in clinical trials. More specifically, the drug was tested in a Phase II study and led to an improvement in estimated glomerular filtration rate (eGFR) over 8 weeks when compared to a placebo. Interestingly, lower doses of GCS-100 had more of an effect than higher doses, which led to no improvement in eGFR.
Unfortunately, in mid-2015, due to FDA roadblocks, La Jolla was forced to abandon their hopes of getting GCS-100 to the US market. It’s not known if the drug will be approved in Europe or elsewhere.
Perhaps the most promising drug on this list, Farxiga, when tested in a groundbreaking Phase III trial, led to a dramatically reduced risk of kidney disease progression and cardiovascular death in both diabetic and non-diabetic CKD patients. The drug was approved in May 2020 for the treatment of heart failure, but AstraZeneca is seeking FDA approval for its use in kidney disease as well.
In December 2020, the results of a 5,700-person Phase III trial were published in the New England Journal of Medicine. The trial, which was spread out over 1,000 different sites in 48 countries, focused on the effectiveness of a drug called Finerenone in treating diabetic kidney disease.
When compared to a placebo, Finerenone was found to slow progression of diabetic kidney disease by a considerable 18 percent over an average of 2.6 years. Currently, the drug has been granted an FDA priority review, and it’s likely that the agency will make a decision on Finerenone’s NDA (new drug application) in the second half of 2021.
With several exciting CKD drugs awaiting FDA approval, being rigorously studied, and even inching closer to market, 2021 is already off to a good start for those who suffer from kidney disease.
- Chronic Kidney Disease Basics | Chronic Kidney Disease Initiative
- Chronic kidney disease is on the rise
- Janssen’s Invokana Becomes First Drug Approved in 20 Years to Slow Diabetic Kidney Disease
- Results from Phase 2 Study of GCS-100 in Chronic Kidney Disease Being Presented at American Society of Nephrology Kidney Week
- La Jolla dumps its NASH drug and shifts its focus to rare disease
- More good news in research: Clinical trials show dramatic results for Farxiga® in treating CKD
- Clinical trial shows experimental drug safely slows progression of diabetic kidney disease
- Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes
- Bayer’s finerenone scores FDA priority review for chronic kidney disease