The FDA, the United States drug regulatory agency, approved this Tuesday (8) the use of Zepbounda drug from pharmaceutical giant Eli Lilly in the form of injectable pen for the treatment of obesity.
The approval of Zepbound makes official, in the USA, the use of a substance already widely prescribed off-label (that is, for a purpose outside the label) for weight loss: tirzepatide.
The drug was already being marketed in the Mounjarobut only for the treatment of diabetes – just like in Brazil, where the substance was approved by the National Health Surveillance Agency (Anvisa) for this purpose.
In a note sent to g1Eli Lilly do Brasil informed that it has already submitted the regulatory submission of the drug’s obesity indication to Anvisa.
In clinical studies that supported its approval, Mounjaro demonstrated superior performance in regulating blood glucose levels and weight loss compared to Ozempic.
According to the drug manufacturer, Zepbound should be available in the United States by the end of the year, in six different doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg), with an estimated list price of 1,059.87 dollars (about R$5,000).
The FDA approved the drug for people considered obese, with a Body Mass Index (BMI) of 30 or more, or for people who are overweight and a related health condition, such as high blood pressure, high cholesterol or diabetes.
The agency also recommended that the medicine be used along with a healthy diet and regular exercise.
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