AstraZeneca PLC — Bydureon EMA EPAR public assessment report (EMEA/H/C/002020, 2011)
AstraZeneca PLC · 2011 · EMA EPAR public assessment report · company profile →
Report summary
AstraZeneca's Type II variation application for Bydureon (exenatide) seeks to extend its indication to adolescents and children aged 10+ with Type 2 Diabetes Mellitus. Study BCB114, a Phase 3, double-blind, placebo-controlled trial, evaluated exenatide once weekly (EQW) in this population. EQW demonstrated a statistically significant reduction in HbA1c (-0.85%) compared to placebo at 24 weeks, though this effect diminished by 52 weeks. Safety findings were consistent with adults, with common adverse events including gastrointestinal issues and injection site reactions. A high incidence of anti-exenatide antibodies was observed in pediatric patients, potentially impacting long-term efficacy. The report supports the drug's indication extension, addressing an unmet medical need.
Key findings — cited to the page
| Study Phase | Phase 3 | Study BCB114 · p.20 |
| Study Design | double-blind, placebo-controlled, randomized, multicenter | Study BCB114 · p.20 |
| HbA1c Inclusion Criteria (taking insulin/SU) | 6.5% to 12.0% % | Study BCB114 · p.20 |
| C-peptide Inclusion Criteria | > 0.6 ng/mL | Study BCB114 · p.20 |
| Percentage of Female Patients (Total) | 58.5 % | Study BCB114 · p.30 |
| Type II variation application submission date | 27 July 2021 | Bydureon · p.6 |
| EMA Decision on Paediatric Investigation Plan (PIP) | P/0064/2021 | Bydureon · p.6 |
| Approval date for Exenatide twice daily (Byetta) in EU | 20 November 2006 | Byetta · EU · p.7 |
| Approval date for BYDUREON (exenatide 2 mg once weekly prolonged-release aqueous formulation) in EU | 17 June 2011 | BYDUREON · EU · p.7 |
| Approval date for BYDUREON BCise (exenatide once weekly prolonged-release non-aqueous suspension via autoinjector) in EU | 27 August 2018 | BYDUREON BCise · EU · p.7 |
| Number of patients randomized to EQW in study BCB114 | 59 | Study BCB114 · p.12 |
| Patient Age Range | 10 to 17 years | Study BCB114 · p.20 |
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 →