this Food and Drug Administration Tuesday approval Novo nordisk‘ Ozempic Treatment of chronic kidney disease with patients with type 2 diabetes, expanding the use of popular injection in the United States
The drug has been widely used and covered with type 2 diabetes. The decision of FDA means that Ozempic can now reduce the risk of worsening kidney diseases, kidney failure and death of patients with chronic kidney disease and diabetic patients with cardiovascular disease.
This decision can change patients with patients who treat chronic kidney disease. This involves the gradual loss of kidney function and One of the main reasons Novo Nordisk said that about 37 million U.S. adults suffer from chronic kidney disease.
Diabetes is a key risk factor for kidney disease. About 40 % Novo Nordisk said that this disease may cause more diseases in patients with type 2 diabetes, such as increasing the risk of cardiovascular problems and death.
NOVO NORDISK’s global chief medical officer Stephen Gough said in an interview: “All chronic kidney diseases are progressing. This is the year -on -year decline in renal function, and renal function has continued to decline.
He pointed out that when the condition develops to the renal failure (also known as the end -stage renal disease), patients need long -term dialysis treatment to eliminate waste or kidney transplants in the blood. According to Gosfu, both of them are heavier, and the death of patients with kidney diseases is “very high”, especially cardiovascular disease.
The approval also shows that a type of severe diabetes and weight loss drugs are called GLP-1. In addition to regulating blood sugar and suppressing appetite, they also have great health benefits.
According to diabetic patients with chronic kidney diseases, Ozempic reduces the risk of severe renal ending, including renal failure, reduced renal function or death of kidney or heart causes of 24 %. result Approval is based on approved post -test.
Among the patients taking Ozempic, the renal function decreases slowly. Compared with placebo, the risk of major cardiovascular events such as heart disease has decreased by 18 %, and the risk of death has dropped by 20 %. OZEMPIC will also reduce the risk of cardiovascular death by 29 %.
“We know, unfortunately, cardiovascular disease and chronic kidney disease are just together.”
He added that the earliest signs of the main treatment of patients with chronic kidney disease aimed at reducing the risk of cardiovascular vascular by paying attention to blood pressure.
Among patients taking Ozempic, the severe adverse side effects rate was 49.6 %, which was lower than 53.8 % in the group of placebo groups. Because gastrointestinal side effects are usually in GLP-1 (such as nausea and vomiting), the incidence of discontinuation of production in Ozempic patients is slightly higher.
EU regulatory agency Get officially recognized Ozempic uses the same use in December.
Novo Nordisk ended the third stage test in October, one year earlier than expected to deal with positive results. At that time, the Danish announcement caused the shares of the kidney dialysis company plum About 20 % within a day.
Trial, call flowBeginning in 2019, about 3500 patients with diabetes and moderate to severe chronic kidney disease.
“From my perspective, as a doctor, you did not get it in isolation (diabetes, obesity, chronic kidney disease and cardiovascular disease).” “Unfortunately, these diseases are polluted. Therefore, if you have a drug that can take these complications in a injection, then you will solve the real thing that is really important for patients. “
The approval is after the Biden government Select NOVO NORDISK’s three drugs have active ingredients of SEMAGLUTIDE for the cycle of the second Medicare drug price negotiation. These include OZEMPIC, which weigh the corresponding object wegovy and another diabetes therapy called Rybelsus.
With the competition of Novo Novo Nordisk Face, the decision of the FDA also appeared Yililai And try to win the scope of welovy’s expansion.
Last year, Weigowei won Agree In the United States, it is used to reduce the risk of large cardiovascular events, such as heart attack and stroke. Novo Nordisk is also studying Wegovy as a potential treatment method Fatty liver diseaseEssence
