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Meeting report, 1-2 July 2025 Paediatric drug Meeting report, 1-2 July 2025 Paediatric drug optimization for epilepsy: meeting report, 1-2 July 2025 © World Health Organization 2025 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/ Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercialpurposes, provided the work is appropriately cited, as indicated below. In any use of this work, thereshould be no suggestion that WHO endorses any specific organization, products or services. The useof the WHO logo is not permitted. If you adapt the work, then you must license your work under the Any mediation relating to disputes arising under the licence shall be conducted in accordance withthe mediation rules of the World Intellectual Property Organization (http://www.wipo.int/amc/en/ Suggested citation.Paediatric drug optimization for epilepsy: meeting report, 1-2 July 2025. Geneva:World Health Organization; 2025. Licence:CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.CIP data are available athttps://iris.who.int/. Sales, rights and licensing. To purchase WHO publications, seehttps://www.who.int/publications/book-orders. To submit requests for commercial use and queries on rights and licensing, seehttps:// Third-party materials.If you wish to reuse material from this work that is attributed to a third party,such as tables, figures or images, it is your responsibility to determine whether permission is needed General disclaimers.The designations employed and the presentation of the material in thispublication do not imply the expression of any opinion whatsoever on the part of WHO concerningthe legal status of any country, territory, city or area or of its authorities, or concerning the The mention of specific companies or of certain manufacturers’ products does not imply that theyare endorsed or recommended by WHO in preference to others of a similar nature that are not All reasonable precautions have been taken by WHO to verify the information contained in thispublication. However, the published material is being distributed without warranty of any kind, eitherexpressed or implied. The responsibility for the interpretation and use of the material lies with the Design and layout by 400 Communications Limited. AcknowledgementsivThe need for paediatric drug optimization1PADO for epilepsy2Objectives3Methods4Meeting proceedings6Summary of discussions6Antiseizure medicines endorsed by WHO6Antiseizure medicines currently not endorsed by WHO10Priority research questions17Conclusions and next steps18References19Annex 1. Categorization of antiseizure medicines and thedevelopment pipeline21Annex 2. Agenda22Annex 3. List of participants24Annex 4. Complete list of medicines approved for epilepsy butnot currently endorsed by WHO25 Acknowledgements The meeting on paediatric drug optimization forepilepsy was co-convened by the WHO ScienceDivision and the WHO Brain Health Unit. TizianaMasini and Katarina Pisani (WHO consultants)led the writing of this meeting report, withcontributions and oversight from WHO staffmembers: Rodrigo Cataldi, Tarun Dua (WHOBrain Health Unit) and Martina Penazzato (WHOScience Division). Asma Hafiz (WHO Science would like to thank the Medicines Patent Poolfor their background work on the patent andmarket aspects of the evaluated products, andSmita Salunke (European Paediatric FormulationInitiative) for assessing the feasibility ofdeveloping paediatric formulations for The need for paediatric Paediatric drug optimization (PADO) exercisesto identify key priority products and theirpreferred product characteristics for researchand development have been successfullyundertaken for human immunodeficiency virus(HIV), hepatitis C, tuberculosis and coronavirusdisease 2019 (COVID-19) demonstrating their The development of medicines forchildren lags unacceptably behind Following the resolution at the Sixty-ninth WorldHealth Assembly on promoting innovation andaccess to quality, safe, efficacious and affordablemedicines for children, WHO and partners haveincreased their efforts to deliver on this globalcommitment and have scaled up activities toensure that age-appropriate formulations are PADO processes are not guideline processesand as such are not intended to endorse the useof products that have not been fully assessedby a WHO guidelines development group.However, prioritization provides a clear signal Developing a priority drug portfolio of the mostneeded formulations for children is essential tostreamline researchers’ and suppliers’ effortsand resources around specific dosage forms Globally, about 52 million people live withepilepsy(4), more than any other chronicneurological disorder(5)and affecting up to1% of children. Data from the Global Burden ofDisease 2021 study show that epilepsy rankssixth in terms of disabi