The U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for deucravacitinib (Sotyktu, Bristol Myers Squibb) for the treatment of adults with active psoriatic arthritis (PsA).
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026. If approved, deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, may be the first TYK2 inhibitor for the treatment of PsA.
This latest regulatory milestone is in addition to the sNDA acceptances by China’s Center for Drug Evaluation of National Medical Products Administration and Japan’s Ministry of Health, Labour and Welfare for deucravacitinib for the treatment of adults with active PsA. The European Medicines Agency has also validated Bristol Myers Squibb’s Type II variation application to expand the indication for deucravacitinib to include this disease.
Deucravacitinib received approval from the FDA in 2022 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Since then, deucravacitinib has earned approvals for this indication from multiple global health authorities.
The regulatory applications are based on positive results from the pivotal POETYK PsA-1 and POETYK PsA-2 trials, which evaluated the efficacy and safety of deucravacitinib in adults with active PsA. Both trials met their primary endpoint, with a significantly greater proportion of Sotyktu-treated patients achieving ACR20 response (at least a 20% improvement in signs and symptoms of disease) after 16 weeks of treatment compared with placebo. Additional data from POETYK PsA-2 reported outcomes through 52 weeks of treatment and demonstrated that clinical response improved and was maintained from Weeks 16 to 52.
The overall safety profile of deucravacitinib through 16 weeks of treatment in the POETYK PsA-1 and POETYK PsA-2 trials was consistent with that established in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials; no new safety signals were observed. Initial results from the POETYK PsA-2 trial were presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in March 2025. Data from both POETYK PsA-1 and POETYK PsA-2 were presented at the European Alliance of Associations for Rheumatology (EULAR) Congress in June 2025. Additional results will be presented at future scientific meetings.
