FDA nod for Sotyktu in moderate-to-severe plaque psoriasis

The US Food and Drug Administration (FDA) late on Friday announced the approval Sotyktu (deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Developed by US pharma major Bristol Myers Squibb (NYSE: BMY), Sotyktu is not recommended for use in combination with other potent immunosuppressants. Sales of $4 billion have been forecast in 2029 by BMS, which is also trialing deucravacitinib in psoriatic arthritis and Crohn’s disease.

The approval is based on results from the pivotal Phase III POETYK PSO-1 and POETYK PSO-2 clinical trials, which demonstrated superior efficacy of once-daily Sotyktu compared to placebo and twice-daily Amgen (Nasdaq: AMGN) drug Otezla (apremilast) in 1,684 patients aged 18 years and older with moderate-to-severe plaque psoriasis. 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.