Pfizer Inc. — Cibinqo EMA EPAR variation assessment report (EMEA/H/C/005452, 2021)
Pfizer Inc. · 2021 · EMA EPAR variation assessment report · company profile →
Report summary
This EMA assessment report evaluates pediatric studies for Cibinqo (abrocitinib), specifically focusing on a retrospective real-world study (B7451126). This study compared abrocitinib to dupilumab and other biologics in adolescent and adult atopic dermatitis patients. While it characterized patient demographics, comorbidities, and healthcare resource utilization, the study lacked robust efficacy and safety data due to limited follow-up, thus providing insufficient evidence for a comprehensive clinical assessment.
Key findings — cited to the page
| Study B7451126 design | retrospective cohort analysis | Study B7451126 · United States · p.4 |
| Approval date for Cibinqo in EU for adults with moderate-to-severe AD | 09 Dec 2021 | Cibinqo · EU · p.4 |
| CHMP Opinion date for Type II Variation to expand Cibinqo indication to adolescents | February 22, 2025 | Cibinqo · p.4 |
| EC Decision date for Type II Variation to expand Cibinqo indication to adolescents | March 21, 2024 | Cibinqo · p.4 |
| Total adolescent patients in Study B7451126 | 1,606 | Study B7451126 · p.6 |
| Adolescent patients in Abrocitinib Treatment Cohort (Study B7451126) | 34 | Study B7451126 · p.6 |
| Adolescent patients in Dupilumab Treatment Cohort (Study B7451126) | 1,538 | Study B7451126 · p.7 |
| Adolescent patients in Other Biologics Treatment Cohort (Study B7451126) | 1,572 | Study B7451126 · p.7 |
| Adolescent patients in Abrocitinib Treatment Cohort with ClinRO or PRO at baseline | 4 | Study B7451126 · p.6 |
| Adolescent patients in Abrocitinib Treatment Cohort with ClinRO or PRO documented at baseline | 11.8 % | Study B7451126 · p.9 |
| Adolescent patients in Dupilumab Treatment Cohort with ClinRO or PRO documented at baseline | 10.9 % | Study B7451126 · p.9 |
| Adolescent patients in Other Biologics Treatment Cohort with ClinRO or PRO documented at baseline | 11.0 % | Study B7451126 · p.9 |
Source: Pfizer Inc. ↗ · 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 Immunology library →