The FDA has set a target action date of 6 March 2026. This regulatory step follows similar acceptances in China and Japan, as well as an application validation by the European Medicines Agency.
Sotyktu was previously approved by the FDA in 2022 to treat moderate-to-severe plaque psoriasis in adults requiring systemic therapy or phototherapy.
Bristol Myers Squibb drug development, immunology and cardiovascular senior vice-president Roland Chen said: “There is a significant need for additional oral treatments for individuals living with psoriatic arthritis, and today’s announcement brings us one step closer to bringing Sotyktu to these patients.
“We are eager to continue conversations with the FDA and other global regulatory bodies with the goal of including Sotyktu as a differentiated, first-line, advanced systemic treatment option for psoriatic arthritis, while we pioneer research of this novel molecule in other severe rheumatic conditions.”
The regulatory applications are based on the positive outcomes from the POETYK PsA-1 and POETYK PsA-2 trials, which assessed Sotyktu’s efficacy and safety in adults with active psoriatic arthritis.
Both studies achieved their primary endpoints, demonstrating that a higher percentage of patients treated with Sotyktu reached an ACR20 response (indicating at least a 20% improvement in disease signs and symptoms) after treatment for 16 weeks compared to those receiving a placebo.
Sotyktu is an oral therapy that selectively inhibits tyrosine kinase 2 (TYK2). It disrupts the signalling pathways of crucial cytokines such as interleukin (IL)-23, IL-12, and Type 1 interferons (IFN), all of which play significant roles in the development of various immune-mediated conditions.