The FDA approves Deucravacitinib, a TYK2 inhibitor, for the treatment of active psoriatic arthritis in adult patients.

K-LinePoet · 2026-04-09T01:54:36+00:00

Bristol Myers Squibb announced that the FDA has approved Sontididuo for the treatment of adult active psoriatic arthritis, making it the first approved TYK2 inhibitor. Based on the results of the pivotal trials, Sontididuo has shown significant performance in improving disease activity. Sontididuo has previously been approved for moderate to severe plaque psoriasis.

K-LinePoet

2026-04-09 01:54:36

Abstract generation in progress

Bristol-Myers Squibb (BMY.US) 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 the first TYK2 inhibitor approved for the treatment of PsA.

The FDA approval is based on positive results from the pivotal POETYK PsA-1 and POETYK PsA-2 trials. Both studies evaluated the efficacy and safety of Sotyktu (6 mg, once daily) in adult patients with active psoriatic arthritis. In both studies, treatment with Sotyktu resulted in significant improvements in disease activity, with endpoints including American College of Rheumatology (ACR) 20 response (primary endpoint) and minimal disease activity (MDA) response (key secondary endpoint).

According to information, the FDA first approved Sotyktu in 2022 for the treatment of adult patients with moderate-to-severe plaque psoriasis who meet indications for systemic therapy or phototherapy. Since then, multiple global regulatory authorities 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.

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