Novo Nordisk drug Ozempic, already a blockbuster vendor in sort 2 diabetes, now has medical trial outcomes displaying it decreased the danger of kidney illness problems by 24%. The corporate is planning U.S. and European regulatory submissions this yr that might develop the drug’s makes use of to incorporate treating persistent kidney illness in sort 2 diabetes sufferers.
The trial outcomes had been anticipated. Final October, Novo Nordisk introduced it could cease the kidney illness examine after the trial met prespecified efficacy targets. Particular particulars weren’t disclosed at the moment, however the firm mentioned knowledge would grow to be accessible within the first half of 2024. The preliminary knowledge reported Tuesday are sparse, however Novo Nordisk mentioned extra however particulars might be introduced at an upcoming scientific assembly.
Ozempic, belonging to a category of medication known as incretins, mimics a intestine hormone to spark metabolic results. The principle ingredient within the drug is a peptide known as semaglutide that’s designed to bind to and activate the GLP-1 receptor. In sufferers with sort 2 diabetes, this mechanism has the impact of regulating blood sugar. Semaglutide’s results on weight led to the approval of the peptide because the weight problems drug Wegovy. Kidney illness represents a possibility for additional increasing Ozempic’s scope.
The Part 3 examine, named FLOW, was designed to indicate whether or not once-weekly injectable Ozempic is superior to a placebo in serving to the kidneys in sufferers with each sort 2 diabetes and persistent kidney illness. The examine enrolled 3,533 individuals in 28 nations. The principle objective is a composite comprised of measuring eGFR, an evaluation of kidney perform; reaching end-stage renal illness; loss of life from kidney illness; or loss of life from heart problems. Novo Nordisk mentioned the 24% discount in kidney illness development and cardiovascular and kidney loss of life was statistically important. The corporate added that its drug additionally confirmed superiority on secondary targets, although specifics weren’t disclosed.
“Roughly 40% of individuals with sort 2 diabetes have persistent kidney illness, so the constructive outcomes from FLOW display the potential for semaglutide to grow to be the primary GLP-1 remedy possibility for individuals residing with sort 2 diabetes and persistent kidney illness,” Martin Holst Lange, govt vice chairman for improvement at Novo Nordisk, mentioned in a ready assertion.
In a observe despatched to buyers, Leerink Companions analyst Joseph Schwartz mentioned his agency is targeted on the annual charge of change in eGFR, a secondary endpoint. This measure makes it simpler for cross-trial comparisons to different medicine on this area. With out detailed eGFR knowledge, the impression of incretins stays unclear, Schwartz mentioned.
Nonetheless, Schwartz mentioned there’s a necessity for added remedies, given the variety of sufferers and the magnitude of Medicare spending on persistent kidney illness. The function of focused therapies for these sufferers may change relying on the adoption of cheaper incretins, related to what’s at the moment occurring with the class of cardiometabolic medicine known as SGLT2 inhibitors.
Ozempic is Novo Nordisk’s top-selling product. The corporate reported Ozempic alone generated 95.7 billion Danish krone (about $13.9 billion) in 2023 income, a 60% enhance over the product’s gross sales within the prior yr. The U.S. is the biggest marketplace for the treatment.
Photograph: Liselotte Sabroe/Scanpix Denmark/AFP, through Getty Photos
