Pediatric Plan (US PSP / EU PIP) — GLPI-103
| Field | Value |
|---|---|
| Document ID | PED-001 |
| Version | 1.0 |
| Standard | FDA PREA/PSP; EU Paediatric Regulation (PIP) |
| Confidentiality | Confidential — portfolio use |
Combined summary of the US Pediatric Study Plan (PSP) and EU Paediatric Investigation Plan (PIP) required for the marketing application.
[MOCK].
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Regulatory | Initial pediatric plan |
1. Condition & Relevance
Type 2 diabetes mellitus occurs in adolescents; a pediatric development plan is required (or a waiver/deferral justified) for the new active substance.
2. Proposed Approach
- Deferral of pediatric studies until adult efficacy/safety is established (pivotal GLPI103-301 complete).
- Planned adolescent (10–<18 y) study of efficacy/safety/PK with appropriate formulation; pediatric PK modeling and extrapolation where scientifically justified.
- Waiver proposed for children below the age where T2DM is not relevant.
3. Regulatory Interactions
PSP agreed with FDA (PREA); PIP agreed with the EMA Paediatric Committee (PDCO), including key binding measures and timelines. Updates submitted as the program matures.