Novo Nordisk's GLP-1 agonist Ozempic 2mg dose approved by US FDA

Compilenewborn

Recently, Novo Nordisk announced that the US FDA has approved Ozempic (semaglutide, semaglutide) 2mg injection

The drug is a glucagon-like peptide-1 (GLP-1) analog administered by subcutaneous injection once a week as an adjunct to dietary modification and exercise: (1) For adults with type 2 diabetes, improve Glycemic control; (2) for adults with type 2 diabetes and heart disease to reduce the risk of major cardiovascular events (heart attack, stroke, death)

Ozempic is not a weight loss drug, but it can help patients lose weight

In the SUSTAIN Phase 3 clinical trial program, up to 73% of patients with type 2 diabetes received Ozempic 1mg treatment with reduced A1C levels and achieved the American Diabetes Association (ADA) blood glucose treatment goals (A1C <7%)

Ozempic is a human GLP-1 analog that stimulates insulin secretion and inhibits glucagon secretion in a glucose concentration-dependent mechanism, and can effectively reduce blood glucose levels in patients with type 2 diabetes with a lower risk of hypoglycemia

Previously, Ozempic has been approved in therapeutic doses of 0.

The FDA approval of Ozempic 2mg Injection was based on results from the SUSTAIN FORTE trial, which enrolled patients with a mean baseline A1C of 8.

In addition, patients in the trial had an average baseline weight of 219 pounds, and at week 40 of treatment, the Ozempic 2 mg group lost 14.

During the trial, no new safety signals were identified for the 2 doses of Ozempic

Reference source:

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