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European Medicines Agency (EMA) recommends Arpraziquantel for treatment of schistosomiasis in preschool-aged children

12 December 2023

  • Arpraziquantel, developed by the Pediatric Praziquantel Consortium, receives positive scientific opinion by the European Medicines Agency for the treatment of schistosomiasis in preschool-aged children
  • EMA assessed Arpraziquantel under the EU-M4all procedure for high-priority medicines intended for use in countries outside the European Union
  • The Consortium’s work to develop, register, and provide access to Arpraziquantel is a tangible contribution to the elimination of schistosomiasis as a public health problem

Today, the Pediatric Praziquantel Consortium announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive scientific opinion for Arpraziquantel to treat the neglected tropical disease, schistosomiasis, in preschool-aged children (3 months to 6 years of age). The application was submitted by Merck, on behalf of the Consortium, under the EU-M4all procedure for high-priority medicines for human use intended for countries outside the European Union.

Read the full EMA opinion here.

“After more than 10 years of intense collaboration, we are thrilled to have received a positive scientific opinion from EMA,” said Dr. Jutta Reinhard-Rupp, Chair of the Pediatric Praziquantel Consortium Board and Head of the Global Health Institute at Merck. “I am extremely proud of our Consortium of dedicated partners. Together, we have come a long way in our vision of providing a treatment option for the most vulnerable population – the youngest. This will contribute to reducing the global disease burden of schistosomiasis, a neglected tropical disease that affects approximately 240 million people worldwide. Now, we all need to turn our full attention to access and delivery.”

Arpraziquantel contains the pharmacologically active enantiomer of praziquantel, the standard of care treatment for schistosomiasis developed in the 1970s. Extending the range of options for the treatment of schistosomiasis, Arpraziquantel is tailored for use in preschool-aged children. It is a 150 mg tablet that withstands the hot and humid challenges presented by a tropical climate. The tablet is to be administered dissolved in water and along with an improved taste that makes it palatable for very young children.

The positive CHMP scientific opinion by EMA is the basis for the potential inclusion of Arpraziquantel into the World Health Organization’s list of prequalified and essential medicinal products. Together with the positive scientific opinion, the planned prequalification will support the regulatory pathway in African countries. In Brazil, regulatory submission is planned by Consortium partner, Farmanguinhos. As the federal governmental pharmaceutical laboratory of the Fiocruz Foundation in Brazil, Farmanguinhos brings expertise in production and distribution and will be the manufacturing site for the future introduction of the new pediatric medication in endemic countries. The partnership with Universal Corporation Ltd., Nairobi, Kenya is also supporting the planned future large-scale local production to serve African countries.

In parallel with this regulatory work, the Consortium’s implementation research program (ADOPT) is currently ongoing, preparing for the introduction of Arpraziquantel in the first endemic countries in Africa. To support equitable and sustainable access, it is essential that new procurement and funding mechanisms are collaboratively explored and established. The intent is to make the product available on a not-for-profit basis in sub-Saharan African countries.

Diseases of poverty, like schistosomiasis, must be overcome in order to deliver on the United Nations’ Sustainable Development Goals (SDGs) and ensure universal health coverage. By developing, registering and providing access to Arpraziquantel, the Consortium is making a tangible contribution to the elimination of schistosomiasis as a public health problem and thereby also addressing the SDGs, in particular SDGs 3 (Good Health and Wellbeing) & 17 (Partnerships for the Goals).

Unlimit Health, as part of the Pediatric Praziquantel Consortium, co-leads on ADOPT with Swiss TPH working alongside consortium partners to ensure access and delivery of the new pediatric formulation in endemic countries.