- The FDA approved Bristol Myers Squibb Co's BMY Sotyktu (deucravacitinib), an allosteric tyrosine kinase 2 (TYK2) inhibitor, for moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
- Sotyktu is not recommended for use in combination with other potent immunosuppressants.
- The approval is based on the Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which demonstrated superior efficacy of once-daily Sotyktu compared to placebo and twice-daily Amgen Inc's AMGN Otezla (apremilast).
- The superior efficacy of Sotyktu compared to placebo and Otezla was demonstrated at both 16 and 24 weeks, and responses with Sotyktu persisted through 52 weeks.
- Concurrently, Bristol Myers announced new two-year results from the POETYK PSO long-term extension (LTE) trial.
- The data demonstrated clinical efficacy with continuous Sotyktu treatment.
- At 112 weeks of Sotyktu treatment, modified non-responder imputation (mNRI) response rates were 82.4% for Psoriasis Area and Severity Index (PASI) 75, 55.2% for PASI 90, and 66.5% for static Physician's Global Assessment (sPGA) 0/1.
- Price Action: BMY shares are up 6.78% at $74.92 during the premarket session on the last check Monday.
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