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The Pediatric Praziquantel Consortium’s regulatory approach
In December 2022, the European Medicines Agency (EMA) validated for review our regulatory application for the potential new pediatric treatment option for schistosomiasis. With this validation and the initiation of the scientific review by EMA, a key milestone was reached in the regulatory phase of the project.
In this short interview, Dr Benjamin Daelken, Senior Director, Global Program Lead of the Consortium, and Global Program Lead of Immunology & Global Health at Merck, summarizes the key steps of our regulatory approach moving forward.
Can you tell us more about the regulatory approach being applied?
The regulatory application to EMA was submitted under the EU-M4all procedure for high-priority medicines for markets outside the European Union. The EMA scientific option is expected by the end of 2023.
According to our validated regulatory approach, a positive opinion from EMA will facilitate the inclusion of the potential new treatment option in the World Health Organization’s list of prequalified and essential medicinal products. It will also support the regulatory pathway for approval in African countries. Regulatory submission in Brazil is also planned.
What are your thoughts regarding the current phase of the project?
I am personally thrilled to be approaching the finish line. Currently, efforts still continue in support of the EMA regulatory process. In parallel, we have worked on a few different fronts: we were successful in publishing the clinical Phase III data in The Lancet Infectious Diseases, the leading journal in this area; and we continue, together with experts, to define the path for sustainable and equitable access to our potential new treatment option, once approved. All of this is critical in finally addressing the large treatment gap affecting millions of pre-schoolers, mainly in sub-Saharan Africa.