Bristol-Myers Squibb Company — Sotyktu EMA EPAR public assessment report (EMEA/H/C/005755, 2023)
Bristol-Myers Squibb Company · 2023 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Sotyktu (deucravacitinib) for moderate to severe plaque psoriasis in adults resulted in a positive marketing authorization opinion. The report details the drug's quality, non-clinical safety, pharmacokinetics, and pharmacodynamics, highlighting its selective TYK2 inhibition. Clinical trials demonstrated deucravacitinib's superior efficacy over placebo and apremilast in improving psoriasis symptoms and patient-reported outcomes, with sustained effects. Safety concerns include increased infection risk, particularly upper respiratory, and potential for malignancies, MACE, and VTE, necessitating ongoing pharmacovigilance. A 6 mg once-daily dose is considered optimal.
Key findings — cited to the page
| Incidence of shifts from baseline of > 2 CTCAE grades in CPK | 1.2 % | · p.172 |
| Incidence of shifts from baseline of > 2 CTCAE grades in CPK | 1.8 % | · p.172 |
| Incidence of shifts from baseline of > 2 CTCAE grades in CPK | 2.6 % | · p.172 |
| CK Grade 2+ events (%) | 4.2 % | · p.84 |
| CK Grade 3+ events (%) | 1.6 % | · p.84 |
| CK Grade 2+ events | 64 | · p.84 |
| CK Grade 3+ events | 24 | · p.84 |
| Number of subjects treated | 6 | IM011016 · p.39 |
| PASI 75 response rates at week 16 (USA) | 44% | IM011046 · United States · p.118 |
| Deucravacitinib tablet strength for Phase 3 psoriasis studies | 6 mg | · p.18 |
| Deucravacitinib retest period | 36 months | · p.17 |
| Deucravacitinib solubility at pH 6.5 | 0.009 mg/mL | · p.15 |
Source: Bristol-Myers Squibb Company ↗ · 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 →