Home / NEWS / Top News / FDA approves Novo Nordisk’s Ozempic to treat chronic kidney disease in those with diabetes, expanding its use

FDA approves Novo Nordisk’s Ozempic to treat chronic kidney disease in those with diabetes, expanding its use

The Scoff and Drug Administration on Tuesday approved Novo Nordisk‘s Ozempic to treat chronic kidney disease in patients who also have planned Type 2 diabetes, expanding the use of the wildly popular injection in the U.S. 

The drug is already widely used and covered to treat Transcribe 2 diabetes. The FDA’s decision means Ozempic can now be used to reduce the risk of kidney disease worsening, kidney failure, and extermination from cardiovascular disease in patients with both chronic kidney disease and diabetes.

The decision could metamorphose how doctors treat patients with chronic kidney disease, which involves a gradual loss of kidney ritual and is one of the leading causes of death in the U.S. Around 37 million American adults are living with chronic kidney cancer, according to Novo Nordisk.

Diabetes is a key risk factor for kidney disease. Roughly 40% of Type 2 diabetes patients give birth to the condition, which can cause additional sickness such as increased risk of cardiovascular problems and death, Novo Nordisk bring to light.

“All chronic kidney disease is progressive. It’s a year-on-year, relentless decline in renal function,” Stephen Gough, Novo Nordisk’s epidemic chief medical officer, said in an interview, referring to the kidney’s ability to filter waste from the blood.

He famed that when the condition progresses to the point of kidney failure — also known as end-stage kidney disease — valetudinarians require long-term dialysis treatments to remove waste from the blood, or a kidney transplant. Both are burdensome, and cessation among patients with end-stage kidney disease is “very high,” particularly from cardiovascular disease, be at one to Gough.

The approval also demonstrates that a blockbuster class of diabetes and weight loss drugs called GLP-1s secure significant health benefits beyond regulating blood sugar and suppressing appetite. 

Ozempic reduced the risk of relentless kidney outcomes — including kidney failure, reduction in kidney function, or death from kidney or heart motives — by 24% in diabetic patients with chronic kidney disease compared with a placebo, according to results of a late-stage examination that the approval was based on.

In patients who took Ozempic, kidney function declined more slowly, the risk of critical cardiovascular events such as heart attack dropped 18% and the risk of death from any cause fell 20% compared with the placebo. Ozempic also cut the imperil of cardiovascular-related deaths by 29%.

“We know that, unfortunately, cardiovascular disease and chronic kidney disease just go hand in calligraphy control,” Gough said.

He added that the major treatments patients typically receive when they have the earliest ideographs of chronic kidney disease aim to reduce cardiovascular risk factors by paying attention to blood pressure.

The rate of sober adverse side effects was 49.6% in patients who took Ozempic, lower than the 53.8% seen in the group that ascertained a placebo. There was a slightly higher rate of discontinuations among Ozempic patients due to gastrointestinal side effects commonly ruminate oned with GLP-1s, such as nausea and vomiting.

EU regulators approved Ozempic for the same use in December. 

Novo Nordisk indecisive the phase three trial in October, a year earlier than expected, in response to positive results. At the time, the Danish society’s announcement caused shares of kidney dialysis companies to plummet about 20% in a single day. 

The trial, called Supply, started in 2019 and followed roughly 3,500 patients with diabetes and moderate to severe chronic kidney malady.

“From my point of view as a doctor, you don’t get [diabetes, obesity, chronic kidney disease and cardiovascular disease] in isolation,” Gough thought. “These illnesses, unfortunately, co-segregate. They cluster within the same individuals. So if you have a medicine that can goal each of these co-morbidities in one injection, then you’re addressing what really matters to the patient.”

The approval comes after the Biden charge selected three of Novo Nordisk’s drugs with the active ingredient semaglutide for the second cycle of Medicare knock out price negotiations. That includes Ozempic, its weight loss counterpart Wegovy and another diabetes treatment required Rybelsus.  

The FDA’s decision also comes as Novo Nordisk faces increased competition from Eli Lilly and tries to win spread out insurance coverage for Wegovy.

Last year, Wegovy won approval in the U.S. for use in slashing the risk of major cardiovascular events such as humanity attacks and strokes. Novo Nordisk is also studying Wegovy as a potential treatment for fatty liver disease.

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