Amgen Inc. — Otezla FDA Review (NDA210745, ORIG 2, 2025)
Amgen Inc. · 2025 · FDA Review (openFDA) · company profile →
Report summary
Amgen's NDA 210745 for Otezla XR (apremilast) 75 mg once-daily seeks approval for active psoriatic arthritis, plaque psoriasis, and oral ulcers associated with Behçet’s disease in adults and specific pediatric populations. The application, with a PDUFA goal of August 30, 2025, follows a complex regulatory history, including ownership transfer from Celgene. Key clinical pharmacology findings confirm bioequivalence between the 75 mg XR and 30 mg IR twice-daily formulations, supported by Study 20200369 and exposure-response analyses. Justification for pediatric use and Behçet’s disease relies on pharmacokinetic bridging and mechanistic evidence. Recent approvals include Otezla for pediatric plaque psoriasis (April 2024) and an sNDA for juvenile psoriatic arthritis (September 2024), with ongoing development for an age-appropriate XR formulation.
Key findings — cited to the page
| IC50 for LPS-induced TNF-α production | 135 ng/mL | · p.37 |
| IC50 for LPS-induced TNF-α production | 294 nM | · p.37 |
| NDA 210745 withdrawal date by Celgene | August 17, 2018 | OTEZLA XR · p.19 |
| Study type | relative bioavailability study | Study 20200369 · p.24 |
| AUC0-24,ss GMR (90% CI) for 75 mg XR once daily vs 30 mg IR twice daily | 0.941 (0.896-0.987) | Study 20200369 · p.25 |
| Cmax GMR (90% CI) for 75 mg XR once daily vs 30 mg IR twice daily | 0.851 (0.820-0.883) | Study 20200369 · p.25 |
| AUC0-24,ss correlation with ACR20 in PsA patients | stronger | Study 157815 · p.25 |
| Ctrough GMR (90% CI) for 75 mg XR once daily vs 30 mg IR twice daily | 0.808 (0.738, 0.884) | Study 20200369 · p.25 |
| AUC0-24,ss correlation with sPGA and PASI-75 in PsO patients | similar | Study 157815 · p.25 |
| Number of subjects enrolled in Study 20200369 Part 1 | 211 | Study 20200369 · p.27 |
| Percentage of subjects completed Study 20200369 Part 1 | 93.4 % | Study 20200369 · p.27 |
| Recommended for approval from clinical pharmacology perspective | Yes | OTEZLA XR · p.25 |
Source: Amgen Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →