Evolution of the European Medicines Agency clinical guidelines for epilepsy drug development between 2010 and 2025: A comparative analysis by the <scp>ILAE</scp> Task Force on Regulatory Affairs
The updated guideline reflects the changing scenario in epilepsy treatment development, with a greater focus on pediatric epilepsies, rare epilepsies, and other indications with high unmet needs. The updates also reflect the contribution during the consultation process by a wide range of stakeholders, including the ILAE Task Force on Regulatory Affairs.
Authors
- S. Auvin
- Kelly G. Knupp (ORCID: https://orcid.org/0000-0002-1967-0827)
- Dennis J. Dlugos
- Alexis Arzimanoglou
- Jacqueline French
- Lieven Lagae
- Eugen Trinka
- Emilio Perucca
Institutions
- European Union (BE)
- Children's Hospital of Philadelphia (US)
- Inserm (FR)
- The University of Melbourne (AU)
- Délégation Paris 7 (FR)
- Institut Universitaire de France (FR)
- Paracelsus Medical University (AT)
- Sorbonne Paris Cité (FR)
- Austrian Institute for Health Technology Assessment GmbH (AT)
- Christian Doppler Klinik (AT)
- Hospital San Juan de Dios (CL)
- Hôpital Robert-Debré (FR)
- Austin Health (AU)
- NeuroDiderot (FR)
- University of Colorado Anschutz Medical Campus (US)
- Monash University (AU)
- New York University (US)
Publication Details
- Journal
- Epilepsia
- Published
- 2026-02-16
- DOI
- https://doi.org/10.1002/epi.70152
- Primary Topic
- Pharmaceutical studies and practices
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- “la Caixa” Foundation
- Jazz Pharmaceuticals
- European Commission
- Eisai
- National Institute of Neurological Disorders and Stroke