ANA BOTTALLO
SÃO PAULO, SP (FOLHAPRESS)
Anvisa (National Health Surveillance Agency) approved this Monday (25) tirzepatide for the treatment of type two diabetes. The approval was published in the Official Gazette of the Union.
Marketed under the name Mounjaro, tirzepatide is a weekly injectable drug that acts on the receptors of two hormones naturally produced in the body, GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide). They work to control blood glycemic levels and the feeling of satiety.
In a phase three clinical trial with around 1,900 participants (Surpass-2), tirzepatide was superior to Ozempic (semaglutide), with a greater reduction in sugar levels in patients with type two diabetes in up to eight weeks, comparing different dosages of tirzepatide (5, 10 and 15 mg) with 1 mg of semaglutide.
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In the same study, half (51%) of the participants who received the high dosage of tirzepatide (15 mg) had a blood sugar level lower than 5.7%, equivalent to that of a normal person, compared to 20% of semaglutide users.
Pharmaceutical Eli Lilly, producer of the drug, said in a statement that the Brazilian agency’s approval was based on the results of the Surpass program, which brought together more than 19,000 participants in 65 study centers around the world, including Brazil.
After authorization from the health agency, the sale price of the medicine will be defined by the CMED (Chamber of Medicines Market Regulation), the body responsible for regulating the price of medicines in the country, within 90 days. It is only after pricing that the company receives approval to sell the medicine in pharmacies.
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Anvisa said, in a note, that in relation to cost, it is up to the company to request the price definition from CMED after the registration is defined.
The senior director of the medical area at Lilly Brasil, the national arm of the American company, stated that it is a historic moment for the company.
“Lilly revolutionized diabetes care when it made the first large-scale insulin available in the world in 1923 and the introduction of human insulin in 1982. Today, we are proud to bring another innovation that will help patients with type two diabetes have a better life,” he said in a statement.
Tirzepatide is an agonist of the hormones GIP and GLP-1. It works by contributing to the secretion of insulin, thus reducing blood sugar levels, and also by reducing food intake and increasing energy expenditure, causing weight loss and control of the glycemic rate.
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In the Surpass-2 study, participants were divided equally into four groups: the first received injectable tirzepatide 5 mg for 40 weeks; the second and third, tirzepatide 10 mg and 15 mg, respectively; and the last group, semaglutide 1 mg.
After the final assessment, participants who received tirzepatide had a reduction in glycemic levels greater than 2% (up to a 2.30% reduction at the highest dosage), while semaglutide users reduced only 1.86%, on average. . Even at the lowest dosage, Mounjaro users achieved a glycemic level of less than 7% (recommended by international diabetes guidelines) within 16 weeks, compared to 24 when treated with Ozempic.
Both tirzepatide and semaglutide had similar side effects, generally mild to moderate, such as nausea (17% to 22%), diarrhea (13% to 16%), vomiting (6% to 10%), and abdominal pain (5% ). Participants receiving Mounjaro experienced more serious adverse events (about 5% to 7%) than Ozempic users (3%).
Like Ozempic, one of the side effects of injectable tirzepatide is weight loss. The average weight of participants at the start of the study was 93.5 kg; In the end, tirzepatide users had an average weight loss of 12.4 kg, approximately twice as much compared to the group treated with semaglutide.
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Despite this beneficial weight loss effect, the FDA (the agency that regulates and inspects foods and medicines in the USA) has not yet approved the use of the medicine to treat obesity.
According to endocrinologist and researcher at the Department of Endocrinology at the PUC-Rio Medical School Alexander Benchimol, tirzepatide proved to be superior to other medications in both improving glycemic control and weight reduction.
“Really, the medication is a milestone in the history of the treatment of type two diabetes. This combination of GIP + GLP-1 brings synergistic benefits in terms of controlling sugar levels and weight loss in treatment that have never been seen before,” he said.
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Regarding adverse effects, doctors state that they were as expected for other drugs that act to regulate the secretion of pancreatic hormones.
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“Every medicine has indications and contraindications, as well as having side effects. The most common effect of this class of drugs is gastrointestinal, such as nausea, vomiting and abdominal pain. They depend on the individual but are also dose dependent, so the higher the dose, the greater the risk”, explains Fábio Moura, director of Sbem (Brazilian Society of Endocrinology and Metabology), who declares that he has no conflict of interest with Lilly.
Even so, doctors assess that the drug’s safety data is robust to support Mounjaro’s approval. “The dosage decision indicated for each patient will be made by the doctor, with the aim of individualizing the treatment, in accordance with clinical trials with thousands of patients”, adds Benchimol.
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