Novo Nordisk’s Ozempic wins FDA approval for chronic kidney disease

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

The drug is already widely used and covered to treat Type 2 diabetes. The FDA’s decision means Ozempic can now be used to cut back the danger of kidney disease worsening, kidney failure, and death from heart problems in patients with each chronic kidney disease and diabetes.

The choice could transform how doctors treat patients with chronic kidney disease, which involves a gradual lack of kidney function and is considered one of the leading causes of death within the U.S. Around 37 million American adults reside with chronic kidney disease, in response to Novo Nordisk.

Diabetes is a key risk factor for kidney disease. Roughly 40% of Type 2 diabetes patients have the condition, which may cause additional sickness corresponding to increased risk of cardiovascular problems and death, Novo Nordisk said.

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

He noted that when the condition progresses to the purpose of kidney failure — also referred to as end-stage kidney disease — patients require long-term dialysis treatments to remove waste from the blood, or a kidney transplant. Each are burdensome, and death amongst patients with end-stage kidney disease is “very high,” particularly from heart problems, in response to Gough.

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

Ozempic reduced the danger of severe kidney outcomes — including kidney failure, reduction in kidney function, or death from kidney or heart causes — by 24% in diabetic patients with chronic kidney disease compared with a placebo, in response to results of a late-stage trial that the approval was based on.

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

“We all know that, unfortunately, heart problems and chronic kidney disease just go hand in hand,” Gough said.

He added that the main treatments patients typically receive once they have the earliest signs of chronic kidney disease aim to cut back cardiovascular risk aspects by taking note of blood pressure.

The speed of great opposed unwanted effects was 49.6% in patients who took Ozempic, lower than the 53.8% seen within the group that received a placebo. There was a rather higher rate of discontinuations amongst Ozempic patients because of gastrointestinal unwanted effects commonly seen with GLP-1s, corresponding to nausea and vomiting.

EU regulators approved Ozempic for a similar use in December. 

Novo Nordisk ended the phase three trial in October, a yr sooner than expected, in response to positive results. On the time, the Danish company’s announcement caused shares of kidney dialysis firms to plummet about 20% in a single day. 

The trial, called FLOW, began in 2019 and followed roughly 3,500 patients with diabetes and moderate to severe chronic kidney disease.

“From my standpoint as a health care provider, you do not get [diabetes, obesity, chronic kidney disease and cardiovascular disease] in isolation,” Gough said. “These illnesses, unfortunately, co-segregate. They cluster inside the same individuals. So if you’ve got a drugs that may goal each of those co-morbidities in a single injection, then you definately’re addressing what really matters to the patient.”

The approval comes after the Biden administration chosen three of Novo Nordisk’s drugs with the energetic ingredient semaglutide for the second cycle of Medicare drug price negotiations. That features Ozempic, its weight reduction counterpart Wegovy and one other diabetes treatment called Rybelsus.  

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

Last yr, Wegovy won approval within the U.S. to be used in slashing the danger of major cardiovascular events corresponding to heart attacks and strokes. Novo Nordisk can be studying Wegovy as a possible treatment for fatty liver disease.