Novo kidney trial finds Ozempic cuts cardiac risks in diabetics

[March 05, 2024]  By Stine Jacobsen and Maggie Fick

COPENHAGEN (Reuters) -Novo Nordisk's widely used diabetes drug Ozempic delayed progression of chronic kidney disease in diabetes patients, a large late-stage study found, cutting the risk of major cardiac events and death by 24%.

Around 40% of people with type 2 diabetes have chronic kidney disease and some 700 million patients are affected globally, according to the Danish drugmaker.

Novo stopped the trial in October, almost a year ahead of schedule, because it was clear from an interim analysis that the treatment would succeed.

"The trial achieved its primary endpoint by demonstrating a statistically significant and superior reduction in kidney disease progression, major adverse cardiovascular events (MACE) and death of 24%," Novo said in a statement on Tuesday.

The trial results are the latest indication that drugs from the GLP-1 class have medical benefits for conditions beyond type 2 diabetes and weight-loss, their initial purposes.

Novo shares, which are up 24% so far this year, were down 1.6% at 1043 GMT, after hitting a record high in early trade.

The 24% reduction in the risk of kidney disease-related events was slightly below some investors' expectations, analysts from Sydbank and Jefferies said.

The trial called FLOW started in 2019 and involved roughly 3,500 patients with type 2 diabetes and moderate to severe chronic kidney disease who were given 1 milligram (mg) of once-weekly semaglutide in addition to standard care.

A box of Ozempic and contents sit on a table in Dudley, North Tyneside, Britain, October 31, 2023. REUTERS/Lee Smith/File Photo

"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," said Novo's head of development, Martin Holst Lange.

Shares in dialysis companies DaVita and Fresenius Medical tumbled last year after Novo announced the early trial success. The dialysis market has for decades been sustained by high rates of obesity and diabetes, which contribute to kidney damage.

The potential for GLP-1s to treat health problems beyond diabetes and obesity has also hit shares in bariatric surgery providers, food firms and glucose-monitoring device makers.

Semaglutide is also the active ingredient in Novo's powerful weight-loss drug Wegovy. Both belong to a class of drugs known as GLP-1 analogues, which mimic hormones and in turn reduce appetite and increase the feeling of fullness after eating.

Novo said it plans to submit an application to EU and U.S. regulators for a label expansion for Ozempic this year.

(Reporting by Stine Jacobsen and Maggie Fick; Editing by Josephine Mason, Terje Solsvik and Alexander Smith)

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