Ozempic, initially approved for Type 2 diabetes, has received FDA approval to mitigate risks associated with chronic kidney disease. A Phase 3 trial demonstrated a 24% reduction in kidney disease progression and a 5% decrease in heart-related death risk for patients with both diabetes and chronic kidney disease.
WASHINGTON - Ozempic, the blockbuster GLP-1 drug that was originally approved to treat Type 2 diabetes, has now also been approved by the U.S. Food and Drug Administration to reduce certain risks associated with chronic kidney disease , drugmaker Novo Nordisk said Tuesday. A Phase 3 clinical trial found that injections of the semaglutide medication once weekly reduced the risk of kidney disease worsening by 24% in people who also had diabetes.
It also reduced the risk of kidney failure and cut the risk of death from heart disease by about 5% in adults with both Type 2 diabetes and chronic kidney disease, the company said in a news release. Chronic kidney disease is a common complication for people living with Type 2 diabetes. Diabetes is the leading cause of kidney failure, which is one of the leading causes of death in the U.S. and worldwide. About a third of adults with diabetes also have chronic kidney disease, according to the U.S. Centers for Disease Control and Prevention. The clinical trial tested the efficacy of Ozempic when added to the standard of care, not as a replacement for other treatments for disease management such as medicines to manage blood pressure, including ACE inhibitors and ARBs. About 3,500 adults across 28 countries were enrolled in the trial, which started in 2019 an
OZEMPIC Chronic Kidney Disease Diabetes FDA Approval GLP-1 Drug
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