Novo Nordisk’s GLP-1 blockbuster Ozempic appears to be making significant strides in the treatment of chronic kidney disease (CKD), potentially reshaping the conventional approach to this condition. However, DaVita, a prominent player in the dialysis industry, is expressing reservations about the findings.
DaVita, a key player in the dialysis sector alongside its German competitor Fresenius, is cautious about the scope of Novo Nordisk’s FLOW trial’s conclusions for the broader CKD population. DaVita points out that it is currently challenging to draw firm conclusions from Novo’s study, given that the detailed results are yet to be disclosed.
Novo Nordisk recently decided to halt the FLOW trial based on the positive performance of Ozempic, acting on the recommendation of the study’s independent data monitoring committee. The trial is expected to unveil its results in the first half of 2024. FLOW assessed Novo’s Ozempic at a 1-mg dose compared to a placebo as an addition to standard care for diabetes patients with CKD, with a focus on determining whether Ozempic can slow down CKD progression and reduce the risk of kidney failure and cardiovascular complications.
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Dialysis, a common treatment for kidney failure, became established in the 1970s, largely due to the progressive damage to kidneys caused by underlying health issues, with diabetes being a major contributor.
DaVita has been closely observing the performance of GLP-1 drugs like Ozempic in CKD, particularly in comparison to another class of diabetes medications known as SGLT2 inhibitors. However, DaVita’s concern lies in the narrow patient inclusion criteria set by Novo. FLOW trial participants had to have both Type 2 diabetes and CKD, along with a history of treatment with standard kidney disease therapies like ACE inhibitors. Additionally, they needed to exhibit a specific level of proteinuria, indicating protein in the urine.
DaVita estimates that fewer than 10% of all CKD patients possess this precise combination of factors. Consequently, further research and studies may be necessary to determine whether FLOW trial findings are applicable to a broader CKD population.
DaVita has also raised questions about the trial’s composite endpoint, which encompasses factors such as the need for dialysis or a kidney transplant. DaVita highlights that findings related to any of these measurements could have triggered the early termination of the FLOW trial.
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Ultimately, it would be a significant breakthrough for CKD patients if FLOW demonstrates that Ozempic can reduce cardiovascular mortality. More CKD patients succumb to cardiovascular disease than those who progress to kidney replacement therapy.
A spokesperson from Novo Nordisk emphasized the company’s commitment to addressing the root cause of CKD, aiming to make a difference in the lives of the 800 million people affected by the disease worldwide.
While it is still early days for Ozempic in CKD, some analysts anticipate that this drug, along with other GLP-1s known for their significant impact on obesity and diabetes, could potentially reduce the number of patients requiring dialysis in the future.
DaVita, which manages a network of over 2,700 outpatient dialysis centers in the US, has seen its stock decline by approximately 18% since Novo’s announcement of the early trial termination. Chronic kidney disease affects 10% of the global population and leads to millions of deaths annually, according to the National Kidney Foundation.
