预约演示

Latest Ozempic results 'move the needle' for treating patients with diabetes, chronic kidney disease: Novo exec

2024-05-24

临床3期临床结果上市批准

While semaglutide has already enjoyed ample popularity, “I do believe that these results really move the needle,” Novo Nordisk's executive medical director Michael Radin, M.D., said.

While semaglutideo overstate the success Novo Nordisk’s GLP-1 franchise has already achieved, the company’s latestNovo Nordisknto semaglutide data in chronic kidney disease (CKD) could help set a new standard for “holistic” care for many diabetes patients, the company’s executive medical director, Michael Radin, M.D., told Fierce Pharma.

Early Friday, Novo shared full results frNovo NordisktriGLP-1sessing the ability of once-weekly semaglutide 1.0 mg to help combat semaglutidey outcomechronic kidney disease (CKD)ss of kidney function and death from kidney or cardiovasculadiabetes in people with Type 2 diabetes and CKD.

Of note in the latest data drop, semaglutide helped slash the risk of major cardiovascular eventsemaglutided reduced the risk of all-cause mortality by 20%. Furkidney failure of kidney function decline over time was “significantly slower” with semaglutide versusType 2 diabetesackedCKD estimated glomerular filtration rate—a common measure of kidney function—Radin said.

Novo presented its detailed look semaglutide results at the 61st meeting of the European Renal Association. The data were also published Friday in The New England Journal of Medicine.semaglutide

The full results come after Novo shared headline data in March that found semaglutide reduced the risk of kidney disease progression and kidney and cardiovascular death by 24%. Back in October, the company halted its FLOW trial early thanks to a positive efficacy signal.

While semaglutide has already enjoyed ample popularity and uptake, “I do bsemaglutide these results reallykidney diseasele,” Radin said.

“In otsemaglutideType 2 diabetes doesn’t exist in a vacuum: These patients often have concomitant cardiovascular disease, they have chronic kidney disease, and there’s a move in the medical community to be able to treat these patients holistically,” he explained.

CKD affects more Type 2 diabetesn people worldwide, according to Novo Nordisk. Some 40% of patientcardiovascular disease also have Cchronic kidney diseaseeventually require dialysis, Radin noted. Those patients are also more likely to die of cardiovascular death.

CKDRadin’s eyes, the FLOW data make "semaglutide stand out uniqueNovo Nordiskhe options that are availablType 2 diabeteswith type 2CKDabetes and chronic kidney disease.”

The medical director pointed to othersemaglutide care for CKD, including Bayer’s Kerendia (finerenone), RAS inhibitors and SGtype 2 diabetes whicchronic kidney diseasecomings. Kerendia and RAS drugs can't help with glycemic control, Radin said, whereas SGLT2 inhibitors’ glycemic efficacy wanes as kidney function worsens.

Safety results in FLOW were on par with semaglutide’s knowCKDrofile in other clinical trialfinerenoneaidRAS inhibitors RAShe Novo exec notSGLT2at “significantly fewer” patients in the trial’s semaglutide group experienced a serious adverse event versus the control armSGLT2ever, more patients on semaglutide discontinued therapy compared to placebo, driven by gastrointestinal disorders, which is consistent with the GLP-1 class as a whole, Radin noted.

Back in March, when Novo unveiled its hesemaglutide in CKD, the company said it would file for regulatory approvals in the U.S. and Europe this year to expand semaglutide’s labesemaglutidedin was unable to provide an update on that front, he confirmed that Novo is sticking by its semaglutidek updated approvals in kidney disease by the end of 2gastrointestinal disorders GLP-1

Elsewhere, Novo is fNovorom done with its semaglutide dCKDlopment journey. The company currently has a functional trial underway in patients with Type 2 diabetsemaglutide peripheral arterial disease with symptomatic claudication, which is set to read out atNovo end of the year, Radin said.kidney disease

In terms of liver health, Novo is also asssemaglutideglutide’s potential ability to help with fibrosis in patients with fatty liver disease and stType 2 diabetesn a phase peripheral arterial disease symptomatic claudication

The company is testing oral semaglutide for its asemaglutideelp people with early Alzheimer’s fibrosisas well. Novo currfatty liver diseases undsteatohepatitispace—evoke and evoke+—which are assessing semaglutide in diabetes and non-diabetes Alzheimer’s populations.

Semaglutide is currently appsemaglutides injectable form as Ozempic for Typeearly Alzheimer’s disease in obesity. Both medicines also boast nods for cardiovascular risk reduction. There's also an oral semaglutide drudiabetes Rybelsusdiabetesbetes.