Amgen Inc. — Otezla EMA EPAR public assessment report (EMEA/H/C/003746, 2015)
Amgen Inc. · 2015 · EMA EPAR public assessment report · company profile →
Report summary
This EMA report details the marketing authorization assessment of Otezla (apremilast) for psoriatic arthritis and moderate to severe chronic plaque psoriasis. It covers the product's quality, pharmaceutical development, and non-clinical aspects, including its mechanism as a PDE4 inhibitor, efficacy in animal models, pharmacokinetics, and toxicology. Extensive clinical trial data (Phase 2 and 3) are presented, demonstrating apremilast's efficacy in improving disease symptoms and physical function in both indications, with consistent improvements in primary and secondary endpoints. The safety profile, derived from pooled analyses, highlights common gastrointestinal and nervous system adverse events, with no increased risk of malignancy or serious infections. The report concludes with a favorable benefit-risk balance, recommending marketing authorization with a comprehensive risk management plan.
Key findings — cited to the page
| Inhibition of IL-1β-induced nitric oxide production by apremilast at 10 µM | 87 % | · p.22 |
| Inhibition of IL-23 p19 and total IL-23 production by apremilast at 1.5 μM | significant inhibitory effects | · p.20 |
| Increase in COX-2 and PGE2 production by apremilast in HPBMCs | 50% to 100% | · p.20 |
| Inhibition of TNF-α, IL-12/IL-23 p40, IP-10, and MCP-1 production by apremilast at 0.5 and 1.5 μM | significant inhibitory effects | · p.19 |
| NOEC for Daphnia sp. Reproduction Test | 6300 µg/L | · p.59 |
| Inhibition of LPS-stimulated TNF-α production | -35.2 % | PSOR-001 · p.82 |
| Inhibition of LPS-stimulated TNF-α production | -5.1 % | PSOR-001 · p.82 |
| US Marketing Authorisation date for psoriasis | 23 September 2014 | Otezla · United States · p.8 |
| Therapeutic indication | Psoriasis | Otezla · p.2 |
| Strengths | 10 mg, 20 mg and 30 mg | Otezla · p.2 |
| Total subjects in PSOR-008 (Safety Population) | 842 | PSOR-008 · p.120 |
| Applicant | Celgene Europe Limited | Otezla · p.2 |
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 →