BMS Korea said Friday that its oral treatment for plaque psoriasis, Sotyktu (deucravacitinib), has obtained approval from the Ministry of Food and Drug Safety.

Sotyktu is a first-in-class selective TYK2 inhibitor that moderates the activity of the IL-23/IL-17 pathway, known to play a central role in the pathogenesis of psoriasis. Sotyktu selectively targeted and inhibited TYK2 signaling and was the first TYK2 inhibitor to be approved.

It is a daily treatment prescribed as a single 6 mg dose that does not require dose adjustment, providing convenience for adult patients with moderate-to-severe plaque psoriasis, candidates for phototherapy or systemic therapy.

The approval is based on the results of POETYK-PSO 1 and 2 studies, which confirmed the clinical efficacy and safety profile of Sotyktu in systemic, phototherapy-naive adult patients with moderate-to-severe plaque psoriasis. The primary endpoints of both studies were the PASI 75 response rate at week 16 and the percentage of patients achieving a Static Physician Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with improvement from baseline equal to or greater than 2 points.

In the POETYK-PSO 1 study, the PASI 75 response rate in the Sotyktu arm reached 58.4 percent at week 16, compared to 35.1 percent in the apremilast arm and 12.7 percent in the placebo arm. The proportion of patients achieving sPGA 0/1 was also significantly higher at 53.6 percent compared to 32.1 percent in the apremilast arm and 7.2 percent in the placebo arm. 

Likewise, the POETYK-PSO 2 study also achieved superior results compared to the placebo. The clinical efficacy of Sotyktu was also observed to be maintained through week 52 of the study. The most common adverse event in both studies was nasopharyngitis, but the incidence of adverse events was similar to that in the control group, and serious adverse events were rare.

"Psoriasis causes psychological stress due to prejudice in addition to physical symptoms, with a high incidence among young adults who are socially active,” said Choe Yong-beom, the president of the Korean Society of Psoriasis. “We believe that the approval of Sotyktu will address the unmet needs of psoriasis patients with convenient once-daily oral dosing, as existing therapies offer inadequate therapeutic efficacy, adverse events, and lack options other than injectable biologics in later stages of treatment."