Bristol Myers Squibb announced on July 21, 2025 that its oral form of deucravacitinib, marketed as Sotyktu for the treatment of active psoriatic arthritis in adults, has had its supplemental new drug application (sNDA) accepted for review by FDA, with a Prescription Drug User Fee Act goal date of March 6, 2026 (1). Other sNDA acceptances for deucravacitinib have been granted in China and Japan, along with the European Medicines Agency’s validation of a Type II variation application to expand the drug’s indication to include psoriatic arthritis.
Two trials show effectiveness
Key Takeaways
- FDA acceptance of Bristol Myers Squibb’s sNDA for Sotyktu (deucravacitinib) in psoriatic arthritis highlights growing interest in oral systemic therapies.
- Positive Phase III data from POETYK PsA-1 and PsA-2 trials support Sotyktu’s potential as a differentiated first-line treatment for rheumatic conditions.
- Global regulatory traction and strategic partnerships signal Bristol Myers Squibb’s broader pipeline expansion in immunology, oncology, and advanced drug delivery.
In a press release, Bristol Myers Squibb said the combined regulatory actions are based on positive results from two trials (POETYK PsA-1 and POETYK PsA-2) that evaluated safety and efficacy with both meeting their primary endpoints after an initial period of 16 weeks, then from 16 weeks to 52 (1).
“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,” Roland Chen, MD, senior vice president, Drug Development, Immunology and Cardiovascular for Bristol Myers Squibb, said in the press release (1). “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.”
A 'drug to watch'
Deucravacitinib had been included on a list of “Drugs to Watch,” in Clarivate’s 2023 report of that name, for the specific indication of treating plaque psoriasis (2). More recently, in April 2025, Bristol Myers Squibb announced FDA’s approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for unresectable or metastatic hepatocellular carcinoma, the most common primary liver cancer (3).
