Brazil: Health Ministry Rejects New Diabetes Kidney Protection Drug for Public System

Brazilian health authorities have denied approval for a new medication intended to protect the kidneys of individuals with diabetes, despite its potential benefits. The decision, made by the Ministry of Health, has sparked debate among medical professionals and patient advocates.

The medication in question is designed to offer additional protection to the kidneys, a common concern for people living with diabetes. Diabetic nephropathy, or kidney disease caused by diabetes, is a serious complication that can lead to kidney failure and the need for dialysis or a kidney transplant. Currently, management focuses on blood sugar control and blood pressure management, alongside medications like ACE inhibitors or ARBs to slow progression.

While the specific name of the medication was not disclosed in reports, the Ministry of Health’s decision underscores the complex considerations involved in introducing new drugs into the Brazilian Unified Health System (SUS). Factors influencing such decisions often include cost-effectiveness, budgetary constraints, and a thorough evaluation of the drug’s efficacy and safety profile.

The denial comes as Brazilian pharmaceutical companies are increasingly focused on developing and marketing generic versions of GLP-1 analogs, a class of drugs that includes semaglutide (Ozempic) and liraglutide. These medications, initially developed for diabetes management, have gained significant attention for their weight-loss effects, leading to increased demand and, at times, shortages. February 21, 2025, pharmaceutical company EMS requested authorization from the U.S. Food and Drug Administration (FDA) to market semaglutide in the United States. EMS has already invested over R$1 billion in liraglutide production within Brazil, positioning itself as a key player in the domestic market for these medications.

The Brazilian Health Regulatory Agency (Anvisa) plays a crucial role in evaluating and approving new drugs and health products. Anvisa is responsible for ensuring the safety and efficacy of medications available to the public, and its decisions are based on scientific evidence and regulatory standards. December 2024, Anvisa approved EMS to produce a sibling compound of Ozempic, with the medication expected to become available in pharmacies in the second half of this year.

The market for GLP-1 analogs in Brazil is substantial, generating approximately R$3 billion annually in sales. From September 2023 to September 2024, sales exceeded R$3 billion, driven by both established pharmaceutical giants like Novo Nordisk and Eli Lilly, and the anticipated entry of generic manufacturers. Brands like Wegovy, Rybelsus, Mounjaro, Trulicity, Saxenda, Victoza, and Ozempic currently dominate the market.

GLP-1 analogs work by mimicking the effects of the naturally occurring hormone GLP-1, which stimulates insulin secretion and delays stomach emptying, leading to increased feelings of fullness. While initially intended for diabetes management, the weight-loss side effect has broadened their appeal and created a surge in demand.

However, the increasing popularity of these medications has also raised concerns about potential misuse and the availability of counterfeit products. December 25, 2024, Anvisa banned the sale of a dietary supplement called Insupril, which falsely claimed to cure diabetes. The agency emphasized that diabetes is a chronic condition with no cure, and that Insupril lacked scientific evidence to support its claims. This action highlights Anvisa’s commitment to protecting public health by cracking down on fraudulent products and misleading advertising.

The situation with Insupril also underscores the importance of reliable health information. Misinformation circulating on social media can lead patients to abandon effective treatments in favor of unproven solutions, potentially jeopardizing their health. Reports on consumer complaint websites like Reclame Aqui indicate that many individuals have been misled by false promises and have experienced problems with the delivery and effectiveness of such products.

The denial of approval for the kidney-protective medication, coupled with the growing market for GLP-1 analogs and the challenges posed by counterfeit products, highlights the complexities of healthcare regulation and access in Brazil. Continued vigilance by Anvisa, coupled with informed decision-making by healthcare providers and patients, will be crucial to ensuring the safe and effective use of medications for diabetes and related conditions.

For individuals with diabetes, maintaining regular check-ups with a healthcare professional is essential for monitoring kidney function and managing the condition effectively. Lifestyle modifications, such as a healthy diet and regular exercise, also play a vital role in protecting kidney health. Patients should always rely on evidence-based medical advice and avoid self-treating with unproven remedies.