AstraZeneca PLC — Bydureon EMA EPAR variation assessment report (EMEA/H/C/002020, 2011)
AstraZeneca PLC · 2011 · EMA EPAR variation assessment report · company profile →
Report summary
AstraZeneca's report details the assessment of exenatide once weekly (Bydureon) for a pediatric Type 2 Diabetes Mellitus indication. The pivotal Phase 3, double-blind, placebo-controlled study (BCB114) in adolescents (10 to <18 years) demonstrated a statistically significant and clinically relevant reduction in HbA1c at 24 weeks, though this effect diminished by Week 52. Safety findings were consistent with the adult profile, with no new concerns. AstraZeneca plans a Type II variation submission in Q4 2021 to update the Bydureon SmPC with this pediatric indication. The report also lists other relevant pharmacokinetic, pharmacodynamic, tolerability, and safety studies.
Key findings — cited to the page
| Bydureon BCise US approval date | 20 October 2017 | Bydureon BCise · United States · p.3 |
| Mean baseline age (placebo group) | 15.6 years | Study BCB114 (D5551C00002) · p.10 |
| Intention to submit Type II variation for paediatric indication | Q4 2021 | Bydureon · p.3 |
| Procedure number for Bydureon | EMEA/H/C/002020/P46/028 | Bydureon · p.1 |
| Paediatric Investigational Plan (PIP) number | EMEA-000689-PIP01-09-M10 | Bydureon · p.3 |
| Mean baseline age (EQW group) | 14.9 years | Study BCB114 (D5551C00002) · p.10 |
| Completion rate of controlled assessment period | 88.0 % | Study BCB114 (D5551C00002) · p.8 |
| Completion rate of open-label extension period | 77.1 % | Study BCB114 (D5551C00002) · p.8 |
| Mean baseline BMI (EQW group) | 36.86 kg/m2 | Study BCB114 (D5551C00002) · p.11 |
| Exenatide prolonged release US approval date | 27 January 2012 | Exenatide prolonged release · United States · p.3 |
| Exenatide prolonged release EU approval date | 17 June 2011 | Exenatide prolonged release · EU · p.3 |
| Mean baseline weight (EQW group) | 102.18 kg | Study BCB114 (D5551C00002) · p.11 |
Source: AstraZeneca PLC ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →