
DaVita Releases Statement Following Stock Sell-Off on Novo Nordisk’s GLP-1 Study Announcement
DaVita, a leading kidney care provider, issued a public statement following developments related to Novo Nordisk’s FLOW study, focusing on the potential benefits of Ozempic®, a glucagon-like peptide 1 (GLP-1) receptor agonist, for patients with chronic kidney disease (CKD) and type 2 diabetes. On October 10, 2023, Novo Nordisk announced that it had decided to halt the FLOW trial, a kidney outcomes study involving semaglutide for individuals with type 2 diabetes and chronic kidney disease. This decision is based on a recommendation from the independent Data Monitoring Committee (DMC) that found the interim analysis met specific criteria for early termination due to efficacy. While the trial is being closed as a result of this interim decision, Novo Nordisk remains unaware of the results to maintain the trial’s integrity. Novo Nordisk announced it will release the results of the FLOW trial results in the first half of 2024. The positive read-through to the data led to a roughly 15% sell-off in DaVita shares over the last few days. DaVita is a major dialysis service provider serving over 200,000 patients in ten countries and investors worry the drugs impact could lessen the need for dialysis services in the future. Other major stocks leveraged to dialysis and kidney disease also sold off such as Fresenius also sold off.
DaVita’s Chief Medical Officer, Dr. Jeff Giullian, was positive regarding the study’s potential but emphasized the need for comprehensive results before drawing conclusions. DaVita highlighted that the FLOW study aims to demonstrate whether Ozempic can delay the progression of CKD and reduce the risks of kidney and cardiovascular mortality in patients with type 2 diabetes. Dr. Giullian acknowledged the medical community’s anticipation of these results and the potential impact of GLP-1s, especially in comparison to SGLT2 inhibitors.
However, he cautioned against drawing premature conclusions, as the FLOW study results are not yet available. DaVita’s concerns are primarily related to the study’s inclusion criteria, which may limit its applicability to the broader CKD patient population. To participate, patients needed to have type 2 diabetes, a CKD diagnosis, and a history of standard treatments, such as ACE inhibitors or ARBs. Additionally, a certain level of proteinuria (protein in the urine) was required. Based on these criteria, DaVita estimates that fewer than 10% of current CKD patients would meet the qualifications for the FLOW study. The study’s endpoints include various factors related to kidney and cardiovascular health, making it essential to understand which endpoint(s) demonstrated positive outcomes to assess the study’s impact fully.
Once Novo Nordisk releases the detailed results of the FLOW study in the first half of 2024, DaVita believes will become clearer whether GLP-1s can reduce cardiovascular mortality, a significant concern for CKD patients. Additionally, the study’s effectiveness in preserving GFR (glomerular filtration rate) will be essential to assess how it compares to other treatments like SGLT2 inhibitors.