the Food and Drug Administration He agreed on Tuesday Novo Nordsk's OzemPic For the treatment of chronic kidney disease in patients also suffering from type 2 diabetes, expand the use of common injection in the United States
The drug is already used on a large scale and covered to treat type 2 diabetes. Food and drug management decision means that OzemPIC can now reduce the risk of exacerbation of kidney disease, kidney failure, and death from cardiovascular disease in patients with chronic kidney disease and diabetes .
The decision can transform how doctors treat patients with chronic kidney disease, which involves a gradual loss of the kidney function and One of the main reasons The death in the United States is about 37 million American adults suffering from chronic kidney disease, according to Novo Nordisk.
Diabetes is a major risk factor for kidney disease. About 40 % Novo Nordisk said that type 2 diabetes have the condition, which can cause additional disease such as increased risk of cardiovascular problems and death.
“All chronic kidney disease is progressive. It is an unabated decrease in kidney function,” said Stephen Gove.
He pointed out that when the condition progresses to the level of kidney failure-also known as kidney disease in the final stage-patients need long-term dialysis treatments to remove waste from blood, or kidney transplant. Both are exhausting, death among patients with kidney disease at the end of the stage “very high”, especially from cardiovascular disease, according to Jawf.
Approval also shows that a group of diabetes and weight loss medications called GLP-1 have significant health benefits that go beyond regulating blood sugar and suppress appetite.
OzemPic reduces the risk of severe kidney results – including kidney failure, decreased kidney function, or death from the causes of the kidneys or heart – by 24 % in diabetics who suffer from chronic kidney disease compared to imaginary therapy. results From the trial of the late stage to which approval was based.
In patients who took OZEMPIC, the kidney function decreased more slowly, the risk of major cardiovascular events such as a heart attack decreased by 18 % and the risk of death from any cause decreased by 20 % compared to the placebo. OzemPIC has also reduced the risk of deaths related to cardiovascular disease by 29 %.
“We know that unfortunately, cardiovascular disease and chronic kidney disease are walking side by side,” said.
He added that the main patients who usually receive it when they have the first signs of chronic kidney disease aims to reduce cardiovascular risk factors through attention to blood pressure.
The serious harmful side effects rate was 49.6 % in patients who took OzemPic, less than 53.8 % who were seen in the collection that was fake. There was a slightly higher rate of stopping among Ozambi patients due to the intestinal side effects that usually witnessed with the GLP-1, such as nausea and vomiting.
Organizers in the European Union consent OzemPic for the same use in December.
Novo Nordsek ended the third stage in October, a year before expected, in response to positive results. At that time, the Danish company announced the shares of dialysis companies Plum About 20 % in one day.
The trial, called flowHe started in 2019 and followed nearly 3,500 patients with diabetes and moderate to acute chronic kidney disease.
“In my view, you do not get (diabetes, obesity, chronic kidney disease and cardiovascular diseases) in isolation.” “These diseases, unfortunately, impose them. They gather within the same individuals. So if you have a drug that can target each of these common diseases in one injection, you really eat the patient.”
The approval comes after the Biden administration specific Three NOVO Nordisk with Semaglutide, the active component of the second cycle of Medicare's pharmaceutical negotiations. This includes OzemPIC, its Wegov weight loss and another diabetes treatment called Rybelsus.
The FDA decision also comes at a time when Novo Nordisk faces an increasing competition from Eli Lily He tries to win the expanded insurance coverage of Wegovy.
Last year, Wigofi won consent In the United States for use to reduce the risk of major cardiovascular events such as heart attacks and strokes. Novo Nordisk also studies Wegovy as a possible treatment for Lipoplasty.
