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Technology transfer of new pediatric treatment option for schistosomiasis advances in Brazil
Two Pediatric Praziquantel Consortium partners, Merck and the Instituto de Tecnologia em Fármacos (Farmanguinhos/Fiocruz) in Brazil, have announced in a local Press Release that their collaboration is leading to Farmanguinhos/Fiocruz becoming the first global producer of the Consortium’s new pediatric treatment option for schistosomiasis in preschool-aged children, between 3 months and 6 years of age.
With the technology transfer from Merck to Farmanguinhos/Fiocruz, production in Brazil will ensure supply in the country after local regulatory approval, as well as in other countries where the disease is highly endemic, especially on the African continent.
The announcement follows two important milestones for the Consortium: (1) a positive scientific opinion of our new treatment option by the European Medicines Agency (EMA) in December 2023 and (2) the inclusion of our new treatment option in the World Health Organization (WHO) List of Prequalified Medicines in May 2024. Regulatory approval is now being sought by Agência Nacional de Vigilância Sanitária (ANVISA) in Brazil, while the roll-out of the new treatment to the first preschool-aged children in Africa is planned for later this year.
To be ready for production and supply, Farmanguinhos/Fiocruz, which already received a Good Manufacturing Practices (GMP) certification by ANVISA, also underwent GMP inspection and certification by EMA, which evaluated the conditions, standards, and processes of medicine production.
“The GMP certification by EMA positively reinforced the technical capacity and quality of the Farmanguinhos/Fiocruz operation,” said Juliana Johansson, responsible for the Technological Development Department of Farmanguinhos/Fiocruz. “We are optimistic about being able to contribute to the solution of such a serious health issue,” she concluded.
Useful links
- Read the original press release (in Brazilian Portuguese) released by Fiocruz and Merck.
- Watch this exclusive interview with a representative from Fiocruz featured on Band TV, a major Brazilian television network (subtitles in English can be activated).