The US Food and Drug Administration (FDA) has granted approval to Novo Nordisk’s diabetes and weight-loss drug, Ozempic, for patients with both chronic kidney disease (CKD) and diabetes. This decision follows positive clinical trial outcomes demonstrating its effectiveness in reducing kidney failure, disease progression, and cardiovascular-related deaths. The approval is based on the FLOW Phase 3b clinical trial, which showed that a 1 mg dose of Ozempic reduced the risk of worsening kidney disease and kidney failure by 24% and decreased the risk of cardiovascular death by 4.9%.
Ozempic contains semaglutide, a GLP-1 receptor agonist that mimics the hormone released by the intestine after meals. This hormone regulates blood sugar by helping the pancreas produce more insulin. Additionally, Ozempic aids weight loss by suppressing appetite and increasing feelings of fullness.
Expert Opinions
Dr. Anoop Misra, Chairman of Fortis CDOC Hospital for Diabetes, emphasized the importance of this breakthrough: “This approval marks a significant breakthrough in managing diabetes-related complications, especially in a population where both kidney disease and obesity are rising concerns.”
Dr. Himanshu Verma, Head of Nephrology at VMMC and Safdarjung Hospital, highlighted the drug’s role in reducing inflammation: “Diabetic patients with kidney disease experience various types of inflammation. Ozempic will act on this inflammatory process, slowing disease progression even in its early stages.”
Implications for India
India faces a growing diabetes epidemic, with a rising prevalence of kidney disease and obesity. The FDA approval of Ozempic could provide much-needed relief for patients in India, where the drug is expected to become available by next year. “Diabetes is the leading cause of kidney disease, and this medicine will be beneficial on a large scale. Prevention is crucial to avoid increasing the economic burden of kidney transplants,” said Dr. Verma.
With its multi-faceted benefits in controlling blood sugar, managing weight, and slowing kidney disease progression, Ozempic could revolutionize the way diabetes and related complications are managed globally. Its arrival in India will be eagerly anticipated by healthcare providers and patients alike.
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