Food and medication administration approved Tuesday Novo Nordisk'S Ozempic to treat chronic kidney disease in patients who also have type 2 diabetes, expanding the use of very popular injection in the United States.
The medicine is already widely used and covered to treat type 2 diabetes. The decision of the FDA means that Ozempic can now be used to reduce the risk of worsening of renal disease, renal failure and death due to cardiovascular disease in patients with chronic renal disease and diabetes.
The decision could transform how doctors treat patients with chronic kidney disease, which implies a gradual loss of renal function and is one of the main causes of death in the United States, around 37 million American adults live with disease Chronic renal, according to Novo Nordisk.
Diabetes is a key risk factor for kidney disease. Approximately 40% of patients with type 2 diabetes have the condition, which can cause additional diseases, such as a greater risk of cardiovascular problems and death, said Novo Nordisk.
“All chronic renal disease is progressive. It is a relentless interannual decrease in renal function,” said Stephen Gough, global medical director of Novo Nordisk, in an interview, referring to the kidney's ability to filter blood waste.
He pointed out that when the condition progresses to the point of renal failure, also known as renal disease in the terminal stage, patients require long -term dialysis treatments to eliminate blood waste or a kidney transplant. Both are heavy, and death among patients with renal disease in the terminal stage is “very high”, particularly due to cardiovascular disease, according to Gough.
The approval also demonstrates that a successful class of diabetes and drug medications called LPG-1 has significant health benefits beyond regulating blood sugar and suppressing appetite.
Ozempic reduced the risk of serious renal results, including renal failure, renal function or death due to renal or cardiac causes, in 24% in diabetic patients with chronic renal disease compared to a placebo, according to the results of A late stage trial on which approval was based.
In patients who took Ozempic, renal function decreased more slowly, the risk of important cardiovascular events, such as heart attack, fell 18% and the risk of death for any cause fell 20% compared to placebo. Ozempic also reduces the risk of cardiovascular deaths by 29%.
“We know that, unfortunately, cardiovascular disease and chronic kidney disease simply go hand in hand,” said Gough.
He added that the main treatments that patients usually receive when they have the first signs of chronic renal disease aim to reduce cardiovascular risk factors when paying attention to blood pressure.
The rate of serious adverse side effects was 49.6% in patients who took Ozempic, less than 53.8% seen in the group that received a placebo. There was a slightly higher rate of discontinuations between patients with Ozempic due to gastrointestinal side effects commonly observed with LPG-1, such as nausea and vomiting.
EU regulators approved Ozempic for the same use in December.
Novo Nordisk ended the three phase trial in October, a year earlier than expected, in response to positive results. At that time, the announcement of the Danish company caused the actions of renal dialysis companies to collapse around 20% in a single day.
The trial, called Flow, began in 2019 and followed approximately 3,500 patients with diabetes and moderate to severe chronic renal disease.
“From my point of view as a doctor, you don't get [diabetes, obesity, chronic kidney disease and cardiovascular disease] Isolated, “said Gough.” These diseases, unfortunately, separate. They are grouped into the same individuals. So, if you have a medicine that can go to each of these comorbidities in an injection, then you are addressing what really matters to the patient. “
The approval is produced after the Biden Administration selected three of the Novo Nordisk medications with the Semaglutida of active ingredients for the second cycle of Medicare medication price negotiations. That includes Ozempic, its Wegovy weight loss counterpart and another diabetes treatment called Rybelsus.
The FDA's decision also occurs when Novo Nordisk faces greater competition from Eli Lilly and tries to gain expanded insurance coverage for Wegovy.
Last year, Wegovy obtained approval in the US. For its use in the risk of large cardiovascular events, such as heart attacks and strokes. Novo Nordisk is also studying cursed as a potential treatment for fatty liver disease.
