Bristol Myers’ sNDA for Sotyktu in psoriatic arthritis accepted by FDA

Bristol Myers (BMY) announced that the FDA has accepted for review the supplemental New Drug Application, or sNDA, for Sotyktu for the treatment of adults with active psoriatic arthritis. The FDA has assigned a Prescription Drug User Fee Act goal date of March 6, 2026. 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 Sotyktu for the treatment of adults with active psoriatic arthritis. The European Medicines Agency has also validated Bristol Myers’ Type II variation application to expand the indication for Sotyktu to include this disease. Sotyktu 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, Sotyktu has earned approvals for this indication from multiple global health authorities and demonstrated durable efficacy and a consistent safety profile over more than 20,000 patient-years of experience.