Bristol Myers' Deucravacitinib Scores FDA Approval For Plaque Psoriasis

  • 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.
Posted In: BiotechLarge CapNewsHealth CareFDAMoversTrading IdeasGeneralBriefswhy it's moving
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!