On 30 August, at this year’s European Society of Cardiology (ESC) conference, during a late-breaking science session on the topic of “Renal Failure and Cardiovascular Disease,” Professor Kenneth Mahaffey presented analysis of the FLOW trial in participants with type 2 diabetes (T2D) and chronic kidney disease (CKD). Mahaffey focused on Novo Nordisk’s Ozempic (semaglutide) to highlight the progress made in glucagon-like peptide-1 (GLP-1) for the management of CKD.
The results presented at ESC showed that the use of Ozempic reduced the risk of cardiovascular death, myocardial infarction, and stroke in subgroups defined by different levels of estimated glomerular filtration rate (eGFR), albuminuria, or Kidney Disease: Improving Global Outcomes (KDIGO) risk class. In addition, Ozempic was also shown to reduce the risk of death from any cause constantly in subgroups defined by eGFR and KDIGO risk class.
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Mahaffey also presented limitations of the FLOW trial, highlighting that the trial was not designed with a sufficient number of events to conclusively evaluate treatment effects in subgroups defined by severity of CKD.
In March 2024, Novo announced positive results from the kidney outcomes trial FLOW. According to the trial, semaglutide 1.0mg reduced risk of kidney disease progression and the risk of kidney and cardiovascular deaths by 24%. Key opinion leaders (KOLs) interviewed by GlobalData have emphasised that unmet needs in the kidney disease space include next-generation therapies with alternate mechanisms of action and enhanced clinical profiles. If approved, Ozempic will become the first GLP-1 therapy option for patients with T2D and CKD.
FLOW was a randomised, double-blind, placebo-controlled, parallel-group, Phase III trial to assess the safety and efficacy of semaglutide when added to standard of care; 3,533 participants with T2D and CKD were enrolled and the safety and tolerability profiles were consistent with previous semaglutide 1.0mg studies. According to KOLs, Ozempic could be an excellent option for patients who are diabetic and obese. In addition, KOLs believe that Ozempic has the potential to be a treatment option for non-diabetic CKD patients whose kidney problems are due to their obesity as opposed to diabetes.
The aging global population will lead to an increase in the prevalence of CKD, leading to an expansion of the market as well as a growing need for more therapeutic options. However, the widespread use of generic CKD drugs continues to make it difficult for high-priced branded therapies to fully penetrate the market.
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By GlobalDataOzempic is a GLP-1 receptor agonist and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. It is formulated as injectable solution for subcutaneous route of administration.
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