AND Food and Drug Administration Tuesday approved Novo Nordiskwith Ground For the treatment of chronic kidney disease in patients who also have type 2 diabetes, expanding use of wild popular injection in the US
The drug is already widely used and covered for the treatment of type 2 diabetes. The FDA Decision means that Orempic can now be used to reduce the risk of deterioration of kidney disease, kidney failure and cardiovascular disease in patients with chronic renal disease and diabetes.
The decision could transform as doctors treat patients with chronic kidney disease, which includes a gradual loss of kidney function and is One of the leading causes Deaths in the United States, about 37 million adult Americans live with a chronic kidney disease, says Novo Nordisk.
Diabetes is a key risk factor for kidney disease. Approximately 40% Patients with type 2 diabetes have a condition, which can cause additional diseases such as increased risk of cardiovascular problems and deaths, Novi Nordisk said.
“All chronic kidney disease is progressive. It is year after year, ruthless decline in renal function,” said Stephen Gough, a global medical clerk Novo Nordisk, interviewing, referring to kidney ability to filter blood waste.
He noted that when the situation progresses to the point of kidney failure and known as the kidney disease in the final stage-pacific requires long-term treatment of dialysis to remove waste from the blood or renal transplant. They are both burdensome, and death among patients with kidney disease in the final stage is “very high”, especially of cardiovascular diseases, Gough states.
Approval also shows that the blockbuster class of diabetes and weight loss drugs called GLP-1 has significant health benefits beyond the regulation of blood sugar and suppression of appetite.
Orempic has reduced the risk of severe renal outcomes – including kidney failure, reduction of kidney function or death from kidney or heart causes – 24% in diabetics with chronic kidney disease compared to placebo, according to data results trials in the late phase on which approval was based.
In patients who took the ground, the kidney function dropped more slowly, the risk of major cardiovascular events, such as a heart attack, dropped 18%, and the risk of death from any cause fell 20% compared to placebo. Orempic also reduced the risk of death associated with a 29%cardiovascular relationship.
“We know that, unfortunately, cardiovascular disease and chronic kidney disease just go hand in hand,” Gough said.
He added that the main remedies that patients usually receive when they have the earliest signs of chronic kidney disease aimed at reducing cardiovascular risk factors by paying attention to blood pressure.
The rate of serious harmful side effects was 49.6% in patients who took the ground, lower than 53.8% recorded in the placebo group. There was a slightly larger interruption rate among the omempian patients due to gastrointestinal side effects that are usually seen with GLP-1, such as nausea and vomiting.
EU regulators approved Orempic for the same use in December.
Novo Nordisk completed the trial of the third phase in October, a year earlier than expected, in response to positive results. At that time, the announcement of the Danish company caused the shares of the kidney dialysis company burning about 20% in one day.
Trial, called FLOWbegan in 2019 and followed by approximately 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.” Unfortunately, these diseases segregate each other. They gather within the same individuals. So, if you have a medicine that can target each of these morabids in one injection, then you deal with the patient, which is actually important. “
Approval comes after the biden administration selected Three drugs Novo Nordisk with active semaglutide ingredients for the second cycle of negotiations on the price of Medicare. This includes Orempic, his weight loss colleague Wegovy and another treatment of diabetes called Rybelsus.
The FDA Decision also comes as Novo Nordisk is facing an increase in competition from Eli Lilly and tries to win the extended insurance insurance for Wegovy.
Last year Wegovy won approval In the United States for use in reducing the risk of major cardiovascular events such as heart attacks and strokes. New Nordisk also studies Wegovy as a potential treatment for Fatty liver disease.
