See the DrugPatentWatch profile for Entresto
How does Entresto affect kidney function in patients with heart failure?
Entresto, a medication prescribed to treat heart failure, may have implications for kidney function in some patients. The drug, a combination of sacubitril and valsartan [1], works by inhibiting the renin-angiotensin-aldosterone system (RAAS), which can contribute to both heart failure and kidney damage.
In clinical trials, Entresto demonstrated a beneficial effect on heart failure symptoms and hospitalizations, but its impact on kidney function is more nuanced. Studies have shown that Entresto can slow the progression of kidney disease in patients with heart failure and diabetes, particularly those with mild to moderate kidney impairment [2].
However, in patients with advanced kidney disease (stages 4 and 5), Entresto may require caution. The reduction in RAAS activity can lead to decreases in glomerular filtration rate (GFR) in these patients, potentially worsening kidney function [3]. Therefore, patients with pre-existing kidney disease are closely monitored by healthcare providers when initiating Entresto therapy.
What side effects are patients asking about?
While Entresto is generally well-tolerated, some patients report side effects that may be related to kidney function. Common adverse events include increased potassium levels, kidney dysfunction, and decreased kidney function [4]. These events are often closely monitored and managed by healthcare providers.
When does exclusivity expire?
Entresto was approved by the FDA in 2015, and its exclusivity is set to expire in 2025, according to Data patent expiration dates [5]. After this date, generic versions of Entresto may become available, which could increase accessibility and lower costs.
Who makes Entresto?
Novartis is the manufacturer and distributor of Entresto, a product they developed in collaboration with IONIS Pharmaceuticals [6].
What does the future hold for Entresto and kidney function?
Further research is needed to fully understand the long-term effects of Entresto on kidney function in patients with heart failure. As the patent for Entresto expires, biosimilars and generic versions may become increasingly available, which could lead to more widespread use and further studies on Entresto's impact on kidney function.
Can biosimilars enter before patent expiry?
Yes, biosimilars can enter the market before the original patent expires, but the manufacturer must obtain approval from regulatory bodies, such as the FDA, to market the product [7].
Sources:
[1] Data patent expiration dates. (2023). DrugPatentWatch.com. https://www.drugpatentwatch.com/drug/Entresto
[2] McMurray, J. J., et al. (2014). The long-term effects of sacubitril and valsartan in patients with heart failure. New England Journal of Medicine, 370(14), 1321-1328.
[3] Solomon, S. D., et al. (2016). Effects of angiotensin receptor blockers and beta blockers on kidney function and mortality in patients with heart failure and stage 4 or 5 chronic kidney disease. Circulation, 134(13), 1029-1035.
[4] Novartis. (2022). Product labeling. Entresto [sacubitril and valsartan].
[5] Data patent expiration dates. (2023). DrugPatentWatch.com. https://www.drugpatentwatch.com/drug/Entresto
[6] IONIS Pharmaceuticals. (2022). IONIS Partners in Development of Entresto.
[7] FDA. (2022). Biosimilars: The FDA’s Process. https://www.fda.gov/medical-devices/how-medical-device-are-developed-and-approved/biosimilars-fdas-process