Novartis AG — Cosentyx EMA EPAR public assessment report (EMEA/H/C/003729, 2015)
Novartis AG · 2015 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Cosentyx (secukinumab) for moderate to severe plaque psoriasis details its administrative information, active substance, pharmaceutical forms, and proposed indication. The report covers manufacturing, quality control, and extensive non-clinical pharmacology, including in vitro and in vivo activity as an IL-17A inhibitor, pharmacokinetics, and toxicology. Clinical development involved numerous studies demonstrating secukinumab's superior efficacy (especially 300 mg and 150 mg doses) over placebo and etanercept in achieving PASI 75/90 and IGA 0/1 responses, with sustained improvements up to 52 weeks. The safety profile is favorable, with common adverse events including infections and neutropenia, but no increase in serious opportunistic infections. The overall benefit-risk balance is positive, supporting its use for plaque psoriasis.
Key findings — cited to the page
| IC50 of secukinumab (Hybridoma/E10908) for cyIL-17A-induced IL-6 production | 44.8 nM | · p.25 |
| IC50 of secukinumab (hybridoma E10908) for cynomolgus monkey IL-17A induced IL-6 production | 44.8 nM | · p.26 |
| IC50 of secukinumab (CHO Process B1/lot 71201) for IL-17AF-induced IL-6 production | 3.30 nM | · p.25 |
| IC50 of secukinumab (Sp2/0 cells/KB03303A) for IL-17A-induced IL-6 production | 0.40 nM | · p.25 |
| IC50 of secukinumab (hybridoma E10908) for IL-17A induced IL-6 production | 0.37 nM | · p.25 |
| IC50 of secukinumab (Sp2/0 cells KB03303A) for IL-17A induced IL-6 production | 0.40 nM | · p.25 |
| IC50 of secukinumab for IL-17A-induced IL-6 production | 2.07 nM | · p.25 |
| IC50 of secukinumab (CHO Process B1/lot 71201) for IL-17A-induced IL-6 production | 0.14 nM | · p.25 |
| IC50 of secukinumab (CHO Process B1/lot 71201) for IL-17F-induced IL-6 production | 1.80 µM | · p.25 |
| IC50 of secukinumab (Hybridoma/E10908) for IL-17A-induced IL-6 production | 0.37 nM | · p.25 |
| IC50 of secukinumab (Sp2/0 cells/KB03303A) for cyIL-17A-induced IL-6 production | 52.0 nM | · p.25 |
| IC50 of secukinumab (Sp2/0 KB03303A) for cynomolgus monkey IL-17A induced IL-6 production | 52 nM | · p.26 |
Source: Novartis AG ↗ · 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 →