Bristol-Myers Squibb Company — Sotyktu FDA Review (NDA214958, ORIG 1, 2022)
Bristol-Myers Squibb Company · 2022 · FDA Review (openFDA) · company profile →
Report summary
The FDA approved Bristol-Myers Squibb's Sotyktu (deucravacitinib) 6 mg tablets for adults with moderate-to-severe plaque psoriasis. Two Phase 3 trials demonstrated Sotyktu's superiority over placebo and apremilast in achieving sPGA 0/1 and PASI 75 at Week 16, with sustained responses at Week 52. While effective, safety concerns include increased CPK, triglycerides, and a reduction in GFR. There were also higher incidences of skin AEs (folliculitis, acne), mouth ulcerations, and infections (herpes simplex, folliculitis, opportunistic infections like herpes zoster). Although serious infection rates were comparable short-term, a potential lymphoma risk was identified. The FDA mandated post-marketing studies to assess long-term safety, including MACE, thrombosis, opportunistic infections, malignancy, and use in pediatric and pregnant populations. Nonclinical reviews supported approval, with no postmarketing commitments. Pharmacokinetic studies support a 6 mg once-daily dosing regimen.
Key findings — cited to the page
| Incidence of shifts of ≥ 2 CTCAE grade increase (deucravacitinib) | 1.9 % | · p.208 |
| Subjects with ≥ 2 CTCAE grade increase (APREM) | 0 subjects | · p.208 |
| Grade 3 hypertriglyceridemia (apremilast) | 2.0 % | · p.208 |
| Grade 4 hypertriglyceridemia (placebo or apremilast) | 0 subjects | · p.208 |
| Incidence of shifts of ≥ 2 CTCAE grade increase (apremilast) | 1.2 % | · p.208 |
| Subjects with ≥ 2 CTCAE grade increase (deucravacitinib) | 0.1 % | · p.208 |
| IGA 0 or 1 with 2 grade improvement | 31 % | Guselkumab (Tremfya) · p.45 |
| Grade 3 hypertriglyceridemia (placebo) | 1.5 % | · p.208 |
| Grade 4 hypertriglyceridemia (deucravacitinib) | 0.2 % | · p.208 |
| Grade 3 hypertriglyceridemia (deucravacitinib) | 1.5 % | · p.208 |
| Incidence of shifts of ≥ 2 CTCAE grade increase (PBO) | 1.8 % | · p.208 |
| Grade 3 hypertriglyceridemia (deucravacitinib) | 2.5 % | · p.208 |
Source: Bristol-Myers Squibb Company ↗ · 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 →