11/12/2023
Farmanguinhos/Fiocruz
Fiocruz, through the Institute of Drug Technology (Farmanguinhos), signed a technical and scientific cooperation agreement on 12/04 to register a generic clone drug for the treatment of Chagas disease with the Brazilian Health Regulatory Agency (Anvisa). The partnership was signed with the German multinational Bayer AG, which owns Nifurtimox®, indicated for the treatment of the disease, with registration approved in the United States, Bolivia, Chile and El Salvador, as an alternative to Benzonidazole. The partnership aims to increase access to drugs for patients through the Unified Health System (SUS, acronym in Portuguese for the Brazilian public health system) .
It is estimated that there are one million people affected by Chagas disease in Brazil, according to the 2021 Chagas Epidemiological Bulletin of the Ministry of Health (MS). The agreement is therefore in line with the mission of Farmanguinhos/Fiocruz, the official laboratory of the Ministry of Health, to offer integrated and sustainable solutions for the SUS.
The drug, produced by Bayer, is recommended, according to the Clinical Protocol and Therapeutic Guidelines for Chagas disease No. 397, of 2018, for the etiological treatment, in children and adolescents in the indeterminate chronic form and, in acute cases, for any age group, in situations where Benznidazole is not adequately tolerated.
Qualified technical staff, resources and materials will therefore be made available to assess the future possibility of transferring production and supply technology for Nifurtimox®. Meanwhile, Farmanguinhos/Fiocruz will be responsible for the registration process with Anvisa, to obtain the relevant certifications to authorize the marketing of the drug on its behalf.