Brazilian regulators greenlight Eli Lilly diabetes drug

Photo: Eli Lilly/Shutterstock

Brazil’s federal health regulator Anvisa on Monday approved tirzepatide, an injection to improve blood sugar control in adults with Type 2 diabetes. Sold under the brand name Mounjaro by U.S. pharmaceutical giant Eli Lilly, tirzepatide was approved by the U.S. Food and Drug Administration back in May 2022.

Type 2 is the most common form of diabetes, a chronic and progressive condition in which the body does not make or use insulin normally, leading to high blood sugar levels. A 2021 report by the International Diabetes Federation (IDF) estimated that around 15.7 million Brazilians have diabetes — or around 10.5 percent of adults aged 20 to 79.

In a press statement, Eli Lilly’s Brazil office highlighted that the medication is a partial treatment, along with diet and exercise. Clinical studies, the company added, showed “unprecedented results in reducing blood sugar levels and weight, determining factors for the successful treatment of the disease.”

Tirzepatide is administered by weekly injections under the skin, with the dose adjusted as tolerated to meet blood sugar goals. According to the FDA, the medication can cause “nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort, and abdominal pain.”

Tirzepatide has gained attention in multiple countries, with many using it off-label to lose weight. A recent 72-week trial, funded by Eli Lilly and whose results were published in The Lancet, showed that “more participants treated with tirzepatide versus placebo met bodyweight reduction thresholds of 5 percent or higher (79-83 percent v. 32 percent).” The drug, however, has been approved exclusively to treat Type 2 diabetes.

Brazil’s Health Ministry has not yet announced plans to purchase tirzepatide. The medication will be submitted to a regulation process under the Medicines Market Regulation Chamber (CMED) for pricing before it can be commercialized.