Access program

The Consortium, in case of a successful outcome of the clinical program, aims to obtain a positive opinion (Article 58) from the EMA in 2023, followed by WHO prequalification and local approval of Levo Praziquantel 150mg in the first African priority countries through the collaborative procedure pathway. Apart from EMA, the Marketing Authorization Application shall be submitted in Brazil.

In collaboration with WHO and external experts, the Consortium has prepared an Access & Delivery plan, that will ensure timely registration, accessibility and affordability of the pediatric praziquantel treatment.

Access and affordability

Once approved, the product will be made available on a not-for-profit basis. Together with relevant stakeholders, the Consortium is exploring new procurement and business models, including local manufacturing, to ensure that the product is available free of charge to the young patients in need. As part of its overall Access strategy, the Consortium is planning a pilot and implementation program in the first African priority countries.

ADOPT

As part of its overall Access strategy, the Consortium is planning a pilot and implementation program in the first African countries named ADOPT1. With partners from schistosome-endemic countries taking a leading role, this program will prepare for the large-scale delivery of the new pediatric medication to treat schistosomiasis in preschool-age children. To this end, the ADOPT program considers aspects ranging from social mobilization and acceptance by the communities, to the assessment of existing drug delivery strategies and setting up monitoring and evaluation frameworks.

The ADOPT program was launched in April 2021 and will run for five years.


Adoption of Levo-Praziquantel 150mg for schistosomiasis by endemic countries