Bristol Myers' Deucravacitinib Under FDA Review For Plaque Psoriasis

The FDA has accepted for review Bristol Myers Squibb & Co's BMY deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis.

  • The European Medicines Agency has also validated the deucravacitinib marketing application for plaque psoriasis.
  • The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 10, 2022. 
  • The regulatory applications are based on positive results from the pivotal POETYK PSO-1 and POETYK PSO-2 trials, which evaluated once-daily deucravacitinib versus placebo and Amgen Inc's AMGN Otezla (apremilast). 
  • Deucravacitinib demonstrated significant and clinically meaningful improvements in skin clearance, symptom burden, and quality of life measures compared to placebo and Otezla. 
  • Deucravacitinib is an oral, selective tyrosine kinase 2 (TYK2) inhibitor.
  • See here Benzinga's Full FDA Calendar.
  • Price Action: BMY shares are down 1.02% at $55.96 during the market session on the last check Monday.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsHealth CareFDAGeneralBriefsPsoriasis
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!