Radiopharmaceutical Florbetaben now produced and marketed by BraIns to identify Alzheimer's, Brazil's most frequent dementia
Although there is no cure, having Alzheimer’s disease is not a death sentence. The earlier it is identified, the better the response to treatments. To improve the diagnosis, the Brain Institute of Rio Grande do Sul (BraIns) began to market the radiopharmaceutical Florbetaben (18F) exclusively in Brazil.
Earlier this month, the National Health Surveillance Agency (Anvisa) authorized the commercialization of the product. Its experimental production began in 2020 and since March 2021 production for research purposes has been made official. With regulation from Anvisa, the product will be distributed to the South and Southeast of the country.
Being the most frequent dementia among the Brazilian population, Alzheimer’s already affects more than 2 million people over 60 years of age. Florbetaben (18F) is a more assertive drug as it marks beta-amyloid plaques in the brain, the biomarkers of Alzheimer’s disease. Developed by the German company Life Molecular Imaging, the product was brought to Brazil in partnership between the Brain Institute and the company R2IBF, which operates in the production of radiopharmaceuticals, with support from the Financiadora de Estudos e Projetos (Finep).
“We know that Alzheimer’s is a disease that not only affects the patient, but also has an impact on everyone around them. Making an accurate diagnosis is not only important for proper treatment, but also to better prepare the family. In the very year we complete 10 years of history, it is a great satisfaction to offer the Brazilian society a radiopharmaceutical that helps in the management of this overwhelming disease. All this was only possible thanks to the great effort of our entire team and our partners Life and Grupo R2IBF”, Louise Hartmann, production coordinator at BraIns, says.
With Anvisa’s authorization, BraIns will produce and supply the radiopharmaceutical to hospitals and clinics, thus becoming a pioneer in the commercialization of this product. Since 2014, the product has been approved by international regulatory bodies, such as the Food and Drug Administration (FDA), in the United States, and the European Medicines Agency (EMA), in Europe.
The Executive Director of Grupo R2IBF, Roberto Vieira, highlights the importance of the partnership signed between BraIns and Grupo R2IBF. “This cooperation allows the two institutions to bring to Brazil the latest developments in the field of Nuclear Medicine, thus enabling the Brazilian population to have access to increasingly innovative radiopharmaceuticals”, he comments.
Described in 1906 by the physician Alois Alzheimer, Alzheimer’s disease is the most common type of dementia, that is, loss of cognitive functions. It is estimated that, today, more than 55 million people live with dementia all over the world. From 60% to 70% of these cases are Alzheimer’s, according to the World Health Organization (WHO).
As the disease is related to aging, these numbers tend to grow proportionally as the population ages. By 2100, individuals over 65 should make up 40% of the Brazilian population, according to the Institute for Applied Economic Research (IPEA). In 2010, the population of elderly people was 7.3%.
Alzheimer’s disease is diagnosed using PET/CT, and radiopharmaceutical Florbetaben to assertively indicate deposits of beta-amyloid substances in the brain. The exam can be booked through the phone (51) 3320-5900. For further information, please go to inscer.pucrs.br.