The Food and Drug Administration on Tuesday approved Novo Nordisk‘s Ozempic for patients with chronic kidney disease and diabetes, expanding the use of the wildly popular injection in 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 reduce the risk of kidney disease worsening, kidney failure and death from cardiovascular disease in patients with both chronic kidney disease and diabetes.
The decision could transform how doctors treat patients with the condition, which involves a gradual loss of kidney function and is one of the leading causes of death in the U.S. Around 37 million American adults are living with chronic kidney disease, according to Novo Nordisk.
Diabetes is a key risk factor for kidney disease. Roughly 40% of Type 2 diabetes patients have the condition, which can cause additional sickness such as increased risk of cardiovascular problems and death, Novo Nordisk said.
“All chronic kidney disease is progressive. It’s 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 point of kidney failure — also known as end-stage kidney disease — patients require long-term dialysis treatments to remove waste from the blood, or a kidney transplant. Both are burdensome and death among patients with end-stage kidney disease is “very high,” particularly from cardiovascular disease, according to Gough.
The approval also demonstrates that a blockbuster class of diabetes and weight loss drugs called GLP-1s have significant health benefits beyond regulating blood sugar and suppressing appetite.
Ozempic reduced the risk 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 to a placebo, according to results of a late-stage trial that the approval was based on.
In patients who took Ozempic, kidney function declined more slowly, the risk of major 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 risk of cardiovascular-related deaths by 29%.
“We know that, unfortunately, cardiovascular disease and chronic kidney disease just go hand in hand,” Gough said.
He added that the major treatments patients typically receive when they have the earliest signs of chronic kidney disease aim to reduce cardiovascular risk factors by paying attention to blood pressure.
The rate of serious adverse side effects was 49.6% in patients who took Ozempic, lower than the 53.8% seen in the group that received a placebo. There was a slightly higher rate of discontinuations among Ozempic patients due to gastrointestinal side effects commonly seen with GLP-1s, such as nausea and vomiting.
EU regulators approved Ozempic for the same use in December.
The Danish company ended the phase three trial in October, a year earlier than expected, in response to positive results. At the time, Novo Nordisk’s announcement caused shares of kidney dialysis companies to plummet about 20% in a single day.
The trial, called FLOW, first started in 2019 and followed roughly 3,500 patients with diabetes and moderate to severe chronic kidney disease.
“From my point of view as a doctor, you don’t get [diabetes, obesity, chronic kidney disease and cardiovascular disease] in isolation,” Gough said. “These illnesses, unfortunately, co-segregate. They cluster within the same individuals. So if you have a medicine that can target each of these co-morbidities in one injection, then you’re addressing what really matters to the patient”
The approval comes after the Biden administration selected three of Novo Nordisk’s drugs with the active ingredient semaglutide for the second cycle of Medicare drug price negotiations. That includes Ozempic, its weight loss counterpart Wegovy and another 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 its separate weight loss injection Wegovy.
Last year, Wegovy won approval in the U.S. for slashing risk of major cardiovascular events such as heart attacks and strokes. Novo Nordisk is also studying Wegovy as a potential treatment for fatty liver disease.
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