Anvisa Approves New Diabetes Type 1 Drug | Brazil News

São Paulo, Brazil – In a significant advancement for those at risk of developing type 1 diabetes, Brazil’s National Health Surveillance Agency (Anvisa) has approved teplizumab, a novel medication designed to delay the onset of the autoimmune disease. The approval, announced on March 10, 2026, offers a new therapeutic option for patients as young as eight years old who are showing early signs of type 1 diabetes but haven’t yet required insulin therapy.

Type 1 diabetes occurs when the body’s immune system mistakenly attacks and destroys the insulin-producing cells in the pancreas. Without insulin, glucose builds up in the bloodstream, potentially leading to serious long-term health complications. This approval represents a crucial step in managing the disease and potentially improving the quality of life for affected individuals.

Teplizumab, marketed as Tzield® by Sanofi, works by modulating the immune system to slow down the destruction of these vital pancreatic cells. According to Anvisa, the medication can delay the require for full insulin treatment – known as stage 3 of the disease – by approximately two years. This delay can be particularly beneficial for children and adolescents, as maintaining stable blood sugar levels can be challenging even with treatment, and prolonged high blood sugar can contribute to heart, kidney, and eye problems.

“This is a significant development, offering families valuable time to prepare for the challenges of managing type 1 diabetes,” said experts. The possibility of delaying the onset of the disease allows for proactive management and potentially reduces the severity of long-term complications.

The Anvisa approval comes alongside the authorization of two other biological products: Datroway®, for advanced breast cancer, and Andembry® (garadacimab), used in the prevention of hereditary angioedema, a rare genetic condition causing severe swelling. Studies indicate Andembry® can reduce the frequency of angioedema crises by over 80% in patients.

In related news, Anvisa likewise announced stricter controls on the prescription and dispensing of GLP-1 agonist medications – often referred to as “weight loss pens” – including semaglutide, liraglutide, dulaglutide, exenatida, tirzepatida, and lixisenatida. Effective April 16, 2025, these medications will require a prescription in duplicate, with the original retained by the pharmacy, similar to antibiotic dispensing protocols. This measure aims to address concerns about adverse events linked to off-label utilize and the increasing demand for these drugs for cosmetic purposes.