Bristol Myers Squibb Submits NDA for TYK2 Inhibitor Sotyktu in Psoriatic Arthritis

▎Armstrong

On July 21, 2025, Bristol-Myers Squibb announced that the FDA had accepted the new indication application for TYK2 inhibitor Sotyktu in treating psoriatic arthritis, with a PDUFA date of March 6, 2026. Sotyktu was previously approved for the treatment of plaque psoriasis.

TYK2 and JAK have significantly different immune responses. TYK2 inhibitors more specifically block IL-12, IL-23, and interferons, without inhibitory effects on other protective cytokines.

The marketing application for Sotyktu is based on data from the Phase III clinical trials POETYK-PsA-1 and POETYK-PsA-2, which reported positive results by the end of 2024. The primary endpoint was the proportion of patients achieving ACR20 response at 16 weeks of treatment. In March 2025, Bristol-Myers Squibb presented the clinical data from POETYK-PsA-2 at the AAD meeting, showing that after 16 weeks of treatment, 54.2% of patients achieved ACR20, compared to 39.4% in the placebo group.

Summary

In addition to psoriasis and psoriatic arthritis, Sotyktu is also being explored for autoimmune indications such as systemic lupus erythematosus and Sjögren's syndrome. Two Phase III clinical trials for systemic lupus erythematosus and one Phase III clinical trial for Sjögren's syndrome are currently underway, with top-line data expected to be released in 2026 and 2027, respectively.