FDA Approves Bristol-Myers Squibb's TYK2 Inhibitor Deucravacitinib for Active Psoriatic Arthritis

Bristol-Myers Squibb (BMY.US) has announced that the U.S. Food and Drug Administration (FDA) has approved Sotyktu® (deucravacitinib) for the treatment of adult patients with active psoriatic arthritis (PsA). Sotyktu is an oral, selective tyrosine kinase 2 (TYK2) inhibitor and is the first TYK2 inhibitor approved for the treatment of PsA. This FDA approval is based on positive results from the pivotal POETYK PsA-1 and POETYK PsA-2 trials. The two studies evaluated the efficacy and safety of Sotyktu (6mg, once daily) in treating adult patients with active psoriatic arthritis. In both studies, treatment with Sotyktu resulted in significant improvements in disease activity, as measured by the American College of Rheumatology (ACR) 20 response (primary endpoint) and Minimal Disease Activity (MDA) response (key secondary endpoint). Data shows that the FDA initially approved Sotyktu in 2022 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Since then, multiple other global regulatory agencies have also approved Sotyktu for this indication. Sotyktu has accumulated five years of clinical efficacy and safety data in the treatment of moderate-to-severe plaque psoriasis.