Dialysis giant DaVita on Thursday raised concerns over Novo Nordisk’s interim analysis of a kidney outcomes study of semaglutide, pointing to the potentially limited applicability of the findings.
Pictured: Entrance to DaVita’s headquarters in Colorado/iStock, JHVEPhoto
Dialysis giant DaVita Inc. on Thursday raised concerns that Novo Nordisk’s diabetes drug Ozempic (semaglutide) would only be beneficial to some patients with chronic kidney disease.
DaVita’s challenge comes days after the Danish drugmaker announced it was stopping the Phase III FLOW trial ahead of schedule because of strong signals of efficacy. The study was evaluating the effects of semaglutide on the worsening of renal impairment and the risk of renal and cardiovascular mortality in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD).
Novo did not provide specific data from FLOW but said that at an interim analysis from an independent Data Monitoring Committee made the recommendation to end the study early. The company is planning to share more data from the study in the first half of 2024.
In its statement on Thursday, DaVita zeroed in on FLOW’s inclusion criteria. Only patients with both T2D and CKD who had previously received standard therapies, such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), were eligible for enrollment in Novo’s study. FLOW also further restricted enrolment to patients positive for proteinuria, according to the dialysis company.
According to DaVita, “fewer than 10% of all current CKD patients” could satisfy this combination of factors.
Davita CMO Jeff Giullian said in a statement that while it is still “nearly impossible” to draw definitive conclusions from the study, “there may be limited application of the FLOW study findings to the overall CKD population” due to its inclusion criteria.
Ozempic will still need to prove itself in future trials to confirm that its benefits in FLOW could also be extended to other CKD patients that fall outside the study’s inclusion criteria, according to DaVita.
The company also pointed to the potential problems of FLOW’s five-pronged composite efficacy endpoint: death from kidney disease, death from cardiovascular disease, sustained decrease in glomerular filtration rate by at least 50%, initiation of replacement therapy and progression to stage 5 CKD.
According to DaVita, “findings on any single endpoint, or any combination thereof, could be sufficient to halt the trial.” It remains unknown which of these five metrics were positively affected by Ozempic treatment.
DaVita is a major kidney care provider in the U.S. As of the end of June 2023, the company estimates that it had provided dialysis services to around 201,000 patients across more than 2,700 outpatient centers across the country. It also runs over 350 outpatient dialysis centers across 11 countries worldwide.
In response to the early termination of FLOW, the company’s stocks dropped 12% on Thursday, according to Seeking Alpha.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
