The National Health Surveillance Agency (Anvisa) has granted registration to Kyinsu, a new drug developed by the pharmaceutical company Novo Nordisk. This product combines icodeca insulin and semaglutide in a single weekly injection.
The decision, formalized in the Official Gazette of the Union (DOU) on Monday (28), introduces Kyinsu as a therapeutic alternative for adults diagnosed with type 2 diabetes who do not achieve adequate control of the condition with currently prescribed treatments.
According to Anvisa information, Kyinsu is pioneering for associating, in a fixed dose and for weekly administration, a basal insulin with a GLP-1 receptor agonist. It is indicated for patients whose type 2 diabetes remains insufficiently controlled with both basal insulin and GLP-1 agonist medications. The treatment regimen must be integrated into an approach that includes diet, physical exercise, and, if necessary, oral anti-diabetic medications.
The formulation aims to integrate different glycemic control methods into a single injection. Icodec insulin functions as a long-acting basal insulin, designed for weekly application, while semaglutide acts as a GLP-1 receptor agonist.
It is important to note that the approval does not imply that Kyinsu is suitable for all individuals with type 2 diabetes. Anvisa restricts its use to adults who show inadequate control of the disease using basal insulin or drugs that modulate the GLP-1 receptor. Treatment selection must be personalized, considering the specific characteristics of each patient and under medical supervision.
Clinical perspectives of the components
Júlio Américo Batatinha, an endocrinologist and doctoral student at the Hospital das Clínicas of the USP School of Medicine, explained to Folha de S.Paulo that the two components work complementarily. Insulin is responsible for maintaining glucose control during periods between meals and during sleep, while semaglutide exerts its action mainly after meals and aids in body weight management.
Batatinha commented that combining these mechanisms in a single weekly injection reduces the number of injections and helps mitigate weight gain and hypoglycemia, effects often linked to increasing the dose of isolated insulin.
Fernanda Parra, an endocrinologist, emphasized that the combination does not suggest that all diabetics need both medications. She stressed that the final indication depends on the specific clinical picture, the level of glycemic control, previous treatments, and the goals defined by the patient.
Parra cited two possible scenarios: one where a patient already uses basal insulin, but whose glycated hemoglobin remains above the individual target, potentially benefiting from the addition of a GLP-1 agonist to improve control without just increasing the amount of insulin; and another scenario involving patients who already use a GLP-1 agonist, such as semaglutide, but still require the action of insulin for satisfactory glycemic control.
Scientific basis and study results
Anvisa's approval was based on a program consisting of three Phase 3 clinical trials, named COMBINE, conducted by Novo Nordisk. This program involved about 2,500 adults with type 2 diabetes at different stages of treatment.
Data presented by the pharmaceutical company showed that the studies evaluated the efficacy and safety of the weekly treatment by combining icodeca insulin and semaglutide in various contexts, including patients already using basal insulin or drugs from the GLP-1 agonist class. Overall, the treatment achieved the expected primary outcomes. The results indicated that the combination resulted in greater reduction of blood glucose and greater weight loss in certain comparisons with the components administered separately. Furthermore, there was a decrease of up to 88% in episodes of severe or significant hypoglycemia when compared to the tested treatments.
Regarding safety and tolerability, the findings were similar to those already known for each component when used separately.
This registration occurs in a country that has one of the largest populations of adults with diabetes in the world. According to the 11th edition of the IDF Diabetes Atlas, Brazil had approximately 16.6 million adults aged 20 to 79 living with diabetes in 2024, representing 10.7% of the population. The country ranked sixth globally in absolute number of people with the disease, and the Atlas estimate suggests this number could rise to around 24 million adults by 2050.
Although the sanitary registration has been obtained, Kyinsu is not yet guaranteed to be available for purchase in Brazil. The registration authorizes commercialization, but procedures related to price definition and distribution logistics are still required before the product reaches Brazilian pharmacies. Currently, there is no disclosure of price or official date for the start of sales in the national territory.