Cosentyx(secukinumab)
Immunology· 3943 cited findings· 5 source documents
Company: Novartis AG →
What the regulatory reviews say
Cosentyx (secukinumab) is approved for the treatment of active psoriatic arthritis (PsA) in patients 2 years of age and older, moderate to severe plaque psoriasis in patients 6 years and older, active ankylosing spondylitis (AS) in adults, and active non-radiographic axial spondyloarthritis. Intravenous use for active psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis was approved on October 10, 2023, following a sBLA submission on September 18, 2023.
Efficacy results include a PASI 75 response rate of 95% and 83%, and an IGA of clear or almost clear in 65% and 62% of patients. Another study showed an IGA mod 2011 score of 0 in 15.3% of patients. Notable safety findings include a nasopharyngitis incidence of 11.4% (compared to 8.6% in placebo), upper respiratory tract infection incidence of 2.5% (compared to 0.7% in placebo), and mucocutaneous infections with candida incidence of 1.2% (compared to 0.3% in placebo). A contraindication exists for serious hypersensitivity to secukinumab or any excipients in COSENTYX.
Key figures — cited to the source page
| PASI 75 response | 95 | NOVARTIS PHARMS CORP — Cosentyx FDA Review (NDA/BLA 125504,, p.26 |
| PASI 75 response | 83 | NOVARTIS PHARMS CORP — Cosentyx FDA Review (NDA/BLA 125504,, p.26 |
| IGA of clear or almost clear | 65 | NOVARTIS PHARMS CORP — Cosentyx FDA Review (NDA/BLA 125504,, p.25 |
| IGA of clear or almost clear | 62 | NOVARTIS PHARMS CORP — Cosentyx FDA Review (NDA/BLA 125504,, p.25 |
| IGA mod 2011 score of 0 | 15.3 | Novartis AG — Cosentyx EMA EPAR public assessment report (EM, p.112 |
| Nasopharyngitis incidence | 11.4% | NOVARTIS PHARMS CORP — Cosentyx FDA Review (NDA/BLA 125504,, p.15 |
| Upper respiratory tract infection incidence | 2.5% | NOVARTIS PHARMS CORP — Cosentyx FDA Review (NDA/BLA 125504,, p.15 |
| Mucocutaneous infections with candida incidence | 1.2% | NOVARTIS PHARMS CORP — Cosentyx FDA Review (NDA/BLA 125504,, p.15 |
Source documents
- NOVARTIS PHARMS CORP — Cosentyx FDA Review (NDA/BLA 125504, 2025) (2025)
- NOVARTIS PHARMS CORP — Cosentyx FDA Review (NDA/BLA 125504, 2025) (2025)
- Novartis AG — Cosentyx EMA EPAR public assessment report (EMEA/H/C/003729, 2015) (2015)
- Novartis AG — Cosentyx EMA EPAR variation assessment report (EMEA/H/C/003729, 2015) (2015)
- Novartis AG — Cosentyx FDA Review (BLA125504, ORIG 1, 2015) (2015)
Compared with
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.