this Food and Drug Administration Tuesday approval Novo nordisk‘ Ozempic For patients with chronic kidney diseases and diabetes, the use of popular injection in the United States
The drug has been widely used and covered with type 2 diabetes. FDA’s decision means that you can use Ozempic to reduce the risk of kidney disease, renal failure and death of chronic kidney disease and cardiovascular disease in patients with diabetic patients.
The decision can change how doctors treat patients’ condition, which 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 Gaofu, the heavier and death of patients with the end of the renal diseases are “very high”, especially cardiovascular disease.
The approval also shows that a type of severe diabetes and weight drugs called GLP-1 have great health benefits, rather than regulating blood sugar and suppressing appetite.
Compared with a placebo 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 -related 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.
The Danish company ended the third stage of trial in October, one year earlier than expected to deal with positive results. At that time, Novo Nordisk announced the stock of kidney dialysis companies plum About 20 % within a day.
Trial, call flowIt started in 2019 and then 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. Individual. Therefore, if you have a drug that targets these complications in one injection, then you can solve the real important thing 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 expanded insurance coverage in exchange for its separate weight loss into Wegovy.
Last year, Weigowei won Agree In the United States, the risk of major cardiovascular events has been reduced, such as heart disease attacks and stroke. Novo Nordisk is also studying Wegovy as a potential treatment method Fatty liver diseaseEssence
