The National Health Surveillance Agency (Anvisa) approved earlier this week the first injection against obesity. The drug semaglutide, with the trade name Wegovy, is indicated for the treatment of overweight and obese adults, starting from a weekly application.
The drug is produced by Novo Nordisk in its industrial plants outside Brazil and will be imported. According to the pharmaceutical company, approval by Anvisa is the first step towards launching the drug in the country.
consulted by CNN the company stated that There is still no set date for the drug to hit the market. .
“After Anvisa’s analysis of compliance, you must wait for the completion of other processes, such as the definition of prices by the Chamber of Regulation of the Medicines Market and even logistics”, says Novo Nordisk.
Drug costs in Brazil
Novo Nordisk says there is no price estimate for Wegovy in the country “still considering that it is being defined by the Medicines Market Regulation Chamber”.
O Wegovy list value in the United States where the drug is marketed and has been approved by the Food and Drug Administration (FDA), it is from $1,349 around R$ 7 thousand.
CNN consulted the Ministry of Health about the incorporation of the drug into the Unified Health System (SUS) and awaits return.
According to Anvisa, semaglutide is indicated as a complementary treatment to a hypocaloric diet and increased physical exercise for weight control, including weight loss and maintenance.
Recommended use is for adult individuals with a baseline Body Mass Index (BMI) of: ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2 to
Wegovy works by modifying a specific receptor, GLP-1 (GLP-1 RA), which is 94% similar to the naturally produced human hormone GLP-1. The molecule induces weight loss, reduces hunger, increases the feeling of satiety, helping the individual to eat less and, consequently, reduce the
The medicine has initial dosage of 0.25mg once a week, and should be adjusted gradually over a 16-week period until reaching the recommended maintenance dose of 2.4mg once a week .
Anvisa authorization context
Anvisa’s authorization was based on the results of the STEP clinical trial program (Semaglutide Treatment Effect in People with Obesity), where it was revealed that patients who used semaglutide (2.4mg) achieved an average body weight loss of 17%, in 68 weeks, against 2.4% of the placebo group (which did not receive the substance). The results were published in scientific journal JAMA.
In addition, one in three patients lost 20% of their body weight, and 83.5% of patients achieved a reduction of 5% or more using Wegovy, versus 31.1% on placebo.
Another highlight of the studies is the improvement of cardiometabolic indices, such as a reduction in abdominal circumference, glycated hemoglobin, triglycerides and blood pressure.
“With this approval, we officially enter a new era in the treatment of obesity, with results in weight reduction never seen before”, says Bruno Halpern, endocrinologist and president of the Brazilian Association for the Study of Obesity and Metabolic Syndrome (Abeso).
The president of the Brazilian Society of Endocrinology and Metabology (SBEM), Paulo Miranda, points out that pharmacological therapy should be based on changes in lifestyle and endocrinological medical follow-up and multidisciplinary team.
“The objective is that the entire process of treatment and control of the patients’ comorbidities is met, generating gains in health and preservation, with a global improvement in the general condition of the patient and not just as a numerical vision of weight loss or even aesthetics”, alert.
According to data from the World Obesity Federation, there are 764 million people living with obesity in the world. The document points out that, by 2030, one in every 5 women and one in every 7 men will have obesity, reaching 1 billion people with obesity globally.
In Brazil, the expectation is that 29 million women, 21 million men and 7.7 million children will be obese by 2030, representing about 30% of the population. Currently, it is estimated that approximately 100 million people are overweight and 41 million live with obesity in the country.
Source: CNN Brasil
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