Latest Ozempic findings 'impact' diabetes, kidney disease treatment: Novo exec

Novo Nordisk’s semaglutide, already a popular medication, is poised for even greater success following new findings regarding its benefits for chronic kidney disease (CKD) in Type 2 diabetes patients. Michael Radin, M.D., Novo Nordisk's executive medical director, remarked on the significant impact of these results, which were recently shared in full from the FLOW trial.

The FLOW trial examined the effects of a 1.0 mg weekly dose of semaglutide on major kidney outcomes. This included assessing its impact on kidney failure, loss of kidney function, and death resulting from kidney or cardiovascular issues in people with Type 2 diabetes and CKD. The data revealed that semaglutide reduced the risk of major cardiovascular events by 18% and all-cause mortality by 20%. Additionally, the decline in kidney function over time was significantly slower in patients treated with semaglutide compared to those who received a placebo. The estimated glomerular filtration rate (eGFR), a common measure of kidney function, was used to track this decline.

The findings were presented at the 61st meeting of the European Renal Association and published in The New England Journal of Medicine. These detailed results follow initial data released in March, which indicated that semaglutide decreased the risk of kidney disease progression and kidney and cardiovascular deaths by 24%. Novo Nordisk had already halted its FLOW trial early in October due to positive efficacy signals.

Radin emphasized that Type 2 diabetes patients often face multiple health challenges, including cardiovascular disease and CKD. Hence, the medical community is moving towards a holistic approach to treat these patients. According to Novo Nordisk, more than 800 million people worldwide suffer from CKD, with around 40% of Type 2 diabetes patients also affected by the disease. These patients often require dialysis and have a higher likelihood of cardiovascular death.

The FLOW trial data, according to Radin, position semaglutide uniquely among existing treatment options for Type 2 diabetes and CKD. Other treatments for CKD, like Bayer’s Kerendia (finerenone), RAS inhibitors, and SGLT2 inhibitors, have limitations. For instance, Kerendia and RAS inhibitors do not aid glycemic control, while the efficacy of SGLT2 inhibitors diminishes as kidney function deteriorates.

Safety profiles from the FLOW trial aligned with semaglutide’s known clinical trial data, Radin pointed out. Fewer serious adverse events were reported in the semaglutide group compared to the control group. However, a higher number of patients on semaglutide discontinued therapy due to gastrointestinal issues, which is consistent with the GLP-1 drug class.

Following the promising headline data announced in March, Novo Nordisk plans to seek regulatory approvals in the U.S. and Europe to expand semaglutide’s label for kidney disease treatment by the end of 2024. Radin reiterated the company's commitment to this timeline.

Novo Nordisk is also exploring semaglutide’s potential in other areas. The company is conducting a trial for Type 2 diabetes patients with peripheral arterial disease and symptomatic claudication, expected to yield results by year-end. Additionally, semaglutide is being evaluated for its potential benefits in liver health, specifically for patients with fatty liver disease and steatohepatitis, through a phase 3 trial.

The company is also investigating oral semaglutide for early Alzheimer’s disease. Two ongoing trials, evoke and evoke+, are assessing the drug's efficacy in both diabetic and non-diabetic Alzheimer’s patient populations.

Semaglutide is currently available in injectable forms as Ozempic for Type 2 diabetes and Wegovy for obesity, both approved for reducing cardiovascular risk. An oral version, Rybelsus, is also available for diabetes.