Diabetes and heart failure: Fiocruz and Boehringer sign agreement for drug

The Institute of Drug Technology (Farmanguinhos/Fiocruz) announced in 2/28 a partnership agreement with the Brazilian unit of the German pharmaceutical company Boehringer Ingelheim in Rio de Janeiro. This is the first step towards submitting and obtaining registration for a generic product of Jardiance®, empagliflozin 10 mg and 25 mg, with the Brazilian Health Regulatory Agency (Anvisa). The drug is indicated for the treatment of adults with type 2 diabetes mellitus, aimed at improving glycemic control. It is also approved by Anvisa to treat patients with heart failure (HF) to reduce the risk of cardiovascular death and hospitalization, in addition to slowing down the loss of kidney function.

Approval of the generic by Anvisa will provide another treatment option for these diseases in the SUS (photo: Viviane Oliveira, Farmanguinhos/Fiocruz)

The approval of the generic drug by Anvisa will allow for another treatment option for these diseases in the Unified Health System (SUS), increasing access for the population. This partnership aims to collaborate with the development of the Health Economic-Industrial Complex (HEIC), strengthening the national production of drugs to meet the potential demands of the SUS.

"This project that we are starting today is the unfolding of a great success of ours for Parkinson's disease with an innovative drug, and this success is now unfolding in a new project for neurodegenerative diseases, which has a very big impact in the field of heart disease and metabolic syndromes in diabetes," said Marco Krieger, vice president of Production and Innovation in Health at Fiocruz. "We are getting started and now the work tends to accelerate, but it is still the cornerstone of the process."

"Boehringer Ingelheim aims to contribute to access to healthcare for the Brazilian population and this technical cooperation agreement marks another important step towards that goal. We are not only expanding the therapeutic options for patients with type 2 diabetes mellitus and heart failure, but also contributing to the strengthening of the Health Economic-Industrial Complex in Brazil," commented the president of Boehringer Ingelheim Brazil, Andrea Sambati. "After the successful partnership with pramipexole, this is another initiative that reinforces our strategic alliance with Farmanguinhos/Fiocruz."

"This agreement reinforces our commitment to the SUS, to finding solutions to the health problems that affect the Brazilian population, as well as contributing to the national production of drugs for diabetes and heart failure. For 47 years, Farmanguinhos has been supplying generic drugs to the SUS, promoting public health by offering integrated and sustainable solutions," said Jorge Mendonça, director of Farmanguinhos/Fiocruz.

Strategic Alliance

The partnership with Boehringer Ingelheim goes back a long way. An agreement signed in November 2011, through a Productive Development Partnership (PDP), guaranteed national autonomy in the production of pramipexole dihydrochloride, used to treat Parkinson's disease. In 2023, Farmanguinhos/Fiocruz supplied SUS with 16,727,000 pharmaceutical units (in concentrations of 0.125mg, 0.250mg and 1.0mg) and the pramipexole produced by the institution was included in Anvisa's list of reference drugs.

The partnership aims to collaborate with the development of the Health Economic-Industrial Complex (photo: Viviane Oliveira, Farmanguinhos/Fiocruz)

Diabetes mellitus

A disease caused by insufficient production or malabsorption of insulin, the hormone that regulates glucose in the blood and ensures energy for the body. Diabetes and high blood sugar are associated with an increased risk of cardiovascular disease.

According to data from the International Diabetes Federation, 537 million adults (aged 20-79) around the world live with diabetes (types 1 and 2). In other words, one in 10 people has the disease. This number is expected to rise to 643 million in 2030 and 784 million in 2045. Type 2 is responsible for around 90% of cases worldwide. In Brazil, the number of adults with this condition is 15.7 million, and 73% of patients in the country are off glycemic target.

Heart failure (HF)

It is a progressive, debilitating and potentially fatal condition that occurs when the heart does not provide adequate blood flow to meet the body's demands for oxygen and nutrients or, in order to do so, retains fluid, leading to increased blood volume, fluid accumulation (congestion) in the lungs and peripheral tissues. Cardiovascular diseases, including heart failure, are the leading cause of mortality and morbidity in the world. In Brazil, HF is the leading cause of hospitalization in people over 60 years old.