Amgen Inc. — Otezla EMA EPAR variation assessment report (EMEA/H/C/003746, 2015)
Amgen Inc. · 2015 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the Type II variation application for Otezla (apremilast) to treat moderate to severe chronic plaque psoriasis in children and adolescents aged 6 years and older. Based on studies PPSO-001, PPSO-003, and PPSO-004, the application demonstrates apremilast's efficacy, with significant improvements in sPGA and PASI-75 responses maintained through 52 weeks. Pharmacokinetic analyses support weight-based dosing (20 mg BID for <50 kg, 30 mg BID for ≥50 kg) to achieve comparable exposure to adults. The safety profile in pediatric patients is consistent with adults, with no new safety concerns identified, though some imbalances in adverse events and treatment effect were noted in subgroups, leading to updated weight monitoring warnings. The CHMP agreed to an extended indication for children aged 6 years and weighing at least 20 kg.
Key findings — cited to the page
| Study PPSO-003 phase | phase 3 | PPSO-003 · p.14 |
| AE rate | 61.4 % | PPSO-003 · p.108 |
| sPGA response rate (DAO) | 58.0 % | PPSO-004 · p.72 |
| Tic | 1 subject | PPSO-004 · p.96 |
| sPGA response rate (DAO) | 58.0 % | PPSO-004 · p.71 |
| Type II variation application submission date | 29 November 2023 | · p.5 |
| CHMP opinion date | 19 September 2024 | · p.6 |
| Proposed indication age range | 6 through 17 years of age | · p.5 |
| Study CC-10004-PPSO-003 phase | phase 3 | CC-10004-PPSO-003 · p.5 |
| Study CC-10004-PPSO-003 design | multi-center, randomised, double-blind, placebo-controlled | CC-10004-PPSO-003 · p.5 |
| Study PPSO-001 phase | phase 2 | PPSO-001 · p.14 |
| sPGA response rate (DAO) | 65.7 % | PPSO-004 · p.71 |
Source: Amgen 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 →