A National Health Surveillance Agency (Anvisa) approved the medicine Mounjarofrom the pharmacist Eli Lilly, to the overweight and obesity treatment. The resolution was published in the edition of the Federal Official Gazette (DOU) of this Monday (9).
According to the publication, the standard is already in force and encompasses different dosages and applications of the pen.
The was already approved for the treatment of, and clinical studies had already shown its effectiveness for weight loss. Now, the pen is approved for the treatment of overweight in the presence of at least one comorbidity and obesity, accompanied by physical activity and low calorie diet.
In this indication, treatment is aimed at adults with body mass index () greater than or equal to 30 (obesity), or greater than or equal to 27 (overweight) with at least one weight-associated comorbidity, such as hypertension, high cholesterol or pre-diabetes.
ANVISA’s approval was based on the SUROUTINT program results, a set of seven phase 3 clinical studies that recruited more than 20,000 patients worldwide.
According to the study, people who used Mounjaro, associated with diet and exercise, presented a higher weight loss when compared to placebo. In the highest dose of treatment (15 mg), individuals lost, on average, 22.5%, while at the lowest dose (5 mg), lost an average of 16% (compared to 0.3% in placebo).
In addition, about 40% of participants who used Mounjaro lost more than 40% of total body weight compared to 0.3% of the placebo group. Participants in the study that reconciled the use of Mounjaro to diet and exercise observed changes in cholesterol and reductions in blood pressure and waist measurement. The changes were secondary outcomes from the use of the medicine, and were not part of the indication of this.
“Unfortunately, despite contrary scientific evidence, obesity is often seen as a lifestyle choice – something people should manage for themselves. For decades, diet and exercise have been the only treatment options, but not all patients can lose weight with this approach,” says Luiz Magno, senior director of Lilly do Brasil, in a statement.
“Thanks to all recent studies, we now know that the body itself can respond to a calorie deficit diet by increasing hunger and reducing the feeling of satiety, that is, the patient’s own metabolism makes weight loss difficult and facilitates the breaking,” explains Magno.
For him, Mounjaro’s approval for obesity brings “more treatment opportunities for those who live with obesity and are looking for better alternatives for weight control”.
What is Mounjaro and how does it work?
The Mounjaro is an injectable drug-based drug, a molecule that acts on the recipients of two hormones produced by the intestine and released after meals: GIP and GLP-1. This means that the drug has the ability to stimulate both GLP-1 and GIP action, increasing insulin production through the pancreas to maintain blood sugar control.
It had already been approved in 2023 for the treatment of type 2 diabetes, and now becomes an option for the treatment of chronic weight control. The drug is considered the main competitor of, also approved for type 2 diabetes, and Wegovy, approved for obesity. Both are from the new pharmacist Nordisk.
MOUNJARO, OZEMPIC and WEGOVY: What are the differences?
While Mounjaro acts on two hormone receptors, Ozepic and WeGovy-both composed of semaglutado, but at different doses-act only on GLP-1 receptors. Semaglutado acts in the secretion of insulin by the pancreas, regulating blood glucose and also promoting the reduction of appetite.
In a recent study, published in May in The New England Journal of Medicine, showed that the.
According to the work, the participants treated with tirzepatida – the molecule that makes up the Mounjaro – reached an average weight reduction of 20.2% compared to 13.7% with semaglutado. On average, the patients using thypatide lost 22.8 kg, while those who were in use of semaglutado lost 15.0 kg. The results were obtained after 72 weeks based on the estimation of treatment regime.
In a main secondary outcome of the same study, tirzepatida has achieved higher results in all body weight reduction targets, with 64.6% of participants in the use of thypatide reaching at least 15% weight loss compared to 40.1% of those treated with semaglutado.
