The Food and Drug Administration approved on Tuesday Novo NordiskThe ozempicin for the treatment of a chronic kidney disease in patients with type -2
The drug is already widespread and covered to treat type -2 diabetes. The decision of the FDA means that Ozempic can now be used to reduce the risk of kidney disease, kidney failure and death from cardiovascular diseases in patients with chronic kidney disease and diabetes.
The decision could change how doctors treat patients with chronic kidney disease, which contains a gradual loss of kidney function, and according to Novo Nordisk is one of the most common causes of death in the United States with chronic kidney diseases with chronic kidney diseases.
Diabetes is an essential risk factor for kidney diseases. About 40% of the type -2 -diabetes patients have the disease that can cause additional diseases, such as: B. an increased risk of cardiovascular problems and death, said Novo Nordisk.
“All chronic kidney diseases are progressive. It is a tireless decline in kidney function compared to the previous year,” said Stephen Gough, Global Chief Medical Officer from Novo Nordisk, in an interview and referred to the ability of the kidney to filter from the blood.
He noted that if the disease is called for kidney disease as a kidney disease in the final stages, patients require long-term dialysis treatments in order to remove waste from the blood or kidney transplant. Both are stressful and death in patients with kidney diseases in the final stage is “very high”, especially for cardiovascular diseases.
The approval also shows that a blockbuster class of diabetes and weight loss medication, which are referred to as GLP-1, have significant health benefits than regulating blood sugar and suppressing appetite.
Ozempic reduced the risk of severe kidney results-in a contempt for kidney failure, reduction in kidney function or death by kidney or heart-caused patients with chronic kidney disease compared to a placebo, according to the results of a study in the late stage, that the approval was based.
In patients who took Ozempic, the kidney function decreased more slowly, the risk of large cardiovascular events such as heart attacks by 18% and the risk of death for any cause compared to placebo. Ozempic also reduced the risk of cardiovascular deaths by 29%.
“We know that cardiovascular diseases and chronic kidney diseases unfortunately simply go hand in hand,” said Gough.
He added that the most important treatment patients typically receive if they have the earliest signs of chronic kidney disease to reduce cardiovascular risk factors by paying attention to blood pressure.
The rate of serious side effects was 49.6% in patients who revenue Ozempic, lower than 53.8% in the group that received a placebo. There was a slightly higher discontinuation rate in ozempic patients due to gastrointestinal side effects that were usually observed in GLP-1 such as nausea and vomiting.
The EU supervisory authorities approved Ozempic for the same use in December.
Novo Nordisk ended phase three study in October, a year earlier than expected, in response to positive results. At that time, the announcement of the Danish company sang around 20% of around 20% of around 20% of around 20% on a single day.
The study called Flow started in 2019 and followed around 3,500 patients with diabetes and moderate to severe chronic kidney diseases.
“From my point of view as a doctor you don't get [diabetes, obesity, chronic kidney disease and cardiovascular disease] Isolated, “said Gough.” Unfortunately, these diseases are common. They group within the same individuals. So if you have a medication that can target each of these comorbidities in an injection, contact what is really important for the patient. “
The admission takes place after the bidders have selected three medication for the second cycle of the Medicare drug price negotiations. This includes Ozempic, his weight loss -opposite Wegovy and another diabetes treatment called Rybelsus.
The decision of the FDA also comes when Novo Nordisk is exposed to Eli Lilly And tries to win an extended insurance cover for Wegovy.
Last year, approval for the risk of the risk of important cardiovascular events such as heart attacks and strokes was received in the United States. Novo Nordisk also examines Wegovy as a potential treatment for fatty liver diseases.
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