Novo Nordisk A.S. said Tuesday a five-year trial of its Ozempic weight-loss drug helped reduce the risk of kidney disease-related events in people with Type 2 diabetes by 24%.
The Danish company disclosed the results of the trial called Flow after it was halted on the recommendation of an independent monitoring committee on Oct. 10, 2023, after showing successful results.
The trial compared injectable semaglutide, which the company markets as Ozempic, with placebo to evaluate its efficacy in treating people with Type 2 diabetes and chronic kidney disease.
Some 3,533 patients participated in the trial, which showed a statistically significant and superior reduction in kidney disease progression as well as cardiovascular and kidney death of 24% for people treated with semaglutide 1.0 mg compared to placebo.
“Further, superiority of semaglutide 1 mg vs placebo was confirmed for the confirmatory secondary endpoints,” the company said in a statement.
Semaglutide proved to be safe and well-tolerated in the trial, in line with earlier 1.0 mg trials.
“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,” said Martin Holst Lange, executive vice president for development at Novo Nordisk
NVO,
The company is planning to file for regulatory approval of a label expansion for Ozempic in the U.S. and European Union in 2024, and will publish detailed results from Flow at a scientific conference.
Jefferies analysts said the reading, while in line with its expectations for a 25% reduction in kidney risk, may disappoint what they called “elevated” expectations.
“It is perhaps below market expectations, in our view,” analysts led by Peter Welford wrote in a note to clients.
“Importantly these results do not expand the addressable GLP-1 population, but do strengthen the case for greater GLP-1 use in Type 2 diabetes as per our market model,” the analysts wrote.
Jefferies has an underperform rating on Novo Nordisk, due to valuation and long-term trends, which include an uncertain ramp-up of Wegovy supply, referring to the company’s other diabetes and weight-loss drug. It also expects more rapid U.S. price erosion, says the space is seeing a lot of competitor readouts and believes that risk exuberance for obesity drugs has peaked.
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GLP-1 refers to the new class of drugs used for diabetes and weight loss that have become highly popular and even led to shortages. GLP stands for glucagon-like peptide. The drugs work by mimicking the effect of GLP-1, a gut hormone that can help control blood-sugar levels and reduce appetite.
The drugs are expected to grow to an audience of 24 million, or nearly 7% of the overall U.S. population, in the next decade, according to a Morgan Stanley note from last year.
Kidney dialysis services companies’ stocks rose early Tuesday, DaVita Inc.,
DVA,
was up 6.4%, while the ADRs of Germany’s Fresenius AG
FMS,
were up 9%.
Boston Scientific Corp.
BSX,
which makes medical devices for kidney issues, was up 0.2%.
Novo Nordisk’s U.S.-listed stock was down 0.9%.
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