FDA approves BMS psoriasis TYK2 inhibitor

Sept. 12, 2022

Bristol Myers Squibb’s Sotyktu just became the first TYK2 inhibitor approved in the world, snagging its FDA approval last week for adults living with moderate-to-severe plaque psoriasis who qualify for systemic therapy or phototherapy. 

The approval hinged on results from BMS’ phase 3 PSO-1 and POETYK PSO-2 clinical trials, which compared Sotyktu (deucravacitinib), to both a placebo and Amgen’s Otezla in a group of  1,684 adults aged 18 years and older. The studies found that Sotyktu had superior efficacy when compared to the two other cohorts at both 16 and 24 weeks, and that positive differences persisted through 52 weeks. 

The co-primary endpoints for the studies were to determine the percentage of patients who had achieved Psoriasis Area and Severity Index 75 and of patients who achieved static Physician's Global Assessment score of 0 or 1 at Week 16 compared to placebo — a scoring tool used to measure the severity and extent of psoriasis and a number to evaluate general disease severity, respectively. 

Sotyktu works by inhibiting tyrosine kinase 2 (TYK2) selectively and allosterically. While the exact mechanism that allows the inhibition of the TYK2 enzyme to provide therapeutic effects in psoriasis patients is unknown, Sotyktu helps stabilize an important interaction between regulatory and catalytic domains of the enzyme. The family of enzymes that TYK2 belongs to helps mediate cytokine pathways and play cell signaling roles, which can be implicated in autoimmune responses. 

The drug is currently under regulatory review by other international agencies for the treatment of both moderate-to-severe plaque psoriasis as well as erythrodermic psoriasis.