New Novo Nordisk Ozempic Data Build Case for Adding Kidney Disease to Label
2024-03-05
临床3期
Novo Nordisk drug OzempicOzempic, already a blockbuster seller in type 2 diabetes, now has clinical trial results showing it reduced the risk of kidney disease complications by 24%. The company is planning U.S. and European regulatory submissions this year that would expand the drug’s uses to include treating chronic kidney disease in type 2 diabetes patients.
The trial results were expected. Last October, Novo Nordisk announced it would stop the kidney disease study after the trial met prespecified efficacy goals. Specific details were not disclosed at that time, but the company said data would become available in the first half of 2024. The preliminary data reported Tuesday are sparse, but Novo Nordisk said more but details will be presented at an upcoming scientific meeting.
OzempicOzempic, belonging to a class of drugs called incretins, mimics a gut hormone to spark metabolic effects. The main ingredient in the drug is a peptide called semaglutide that is designed to bind to and activate the GLP-1 receptor. In patients with type 2 diabetes, this mechanism has the effect of regulating blood sugar. Semaglutide’s effects on weight led to the approval of the peptide as the obesity drug Wegovy. Kidney disease represents an opportunity for further expanding OzempicOzempic’s scope.
The Phase 3 study, named FLOW, was designed to show whether once-weekly injectable OzempicOzempic is superior to a placebo in helping the kidneys in patients with both type 2 diabetes and chronic kidney disease. The study enrolled 3,533 participants in 28 countries. The main goal is a composite comprised of measuring eGFR, an assessment of kidney function; reaching end-stage renal disease; death from kidney disease; or death from cardiovascular disease. Novo Nordisk said the 24% reduction in kidney disease progression and cardiovascular and kidney death was statistically significant. The company added that its drug also showed superiority on secondary goals, though specifics were not disclosed.
“Approximately 40% of people with type 2 diabetes have chronic kidney disease, so the positive results from FLOW demonstrate the potential for semaglutide to become the first GLP-1 treatment option for people living with type 2 diabetes and chronic kidney disease,” Martin Holst Lange, executive vice president for development at Novo Nordisk, said in a prepared statement.
In a note sent to investors, Leerink Partners analyst Joseph Schwartz said his firm is focused on the annual rate of change in eGFR, a secondary endpoint. This measure makes it easier for cross-trial comparisons to other drugs in this space. Without detailed eGFR data, the impact of incretins remains unclear, Schwartz said.
However, Schwartz said there’s a need for additional treatments, given the number of patients and the magnitude of Medicare spending on chronic kidney disease. The role of targeted therapies for these patients could change depending on the adoption of cheaper incretins, similar to what is currently happening with the class of cardiometabolic drugs called SGLT2 inhibitors.
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