The U.S. Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Sotyktu, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, was given the go-ahead by the FDA on September 9, 2022. This came after results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials demonstrated superior efficacy of once-daily Sotyktu compared to placebo and twice-daily Otezla (apremilast) at both 16 and 24 weeks. This efficacy persisted through 52 weeks.
With approximately two million cases of plaque psoriasis in the U.S considered moderate to severe, the approval of Sotyktu is greeted with much hope and excitement.
Leah M. Howard, JD, President and CEO of the National Psoriasis Foundation states, “The FDA approval of a new oral treatment is exciting news for the psoriasis community. We welcome this new treatment option.”
“Sotyktu has the potential to become the new standard of care oral treatment for people with moderate-to-severe plaque psoriasis, given its profile in helping patients achieve clearer skin as demonstrated in the POETYK PSO clinical program,” said April W. Armstrong, MD, MPH, clinical investigator in the POETYK PSO-1 trial and Associate Dean and Professor of Dermatology at the University of Southern California. She adds that “people living with moderate-to-severe plaque psoriasis face significant burdens, and Sotyktu is a welcome first-line systemic treatment option.”