FDA Accepts sNDA for Sotyktu in PsA

Image Credit: © DermNet

Today, Bristol Myers Squibb announced the supplemental New Drug Application (sNDA) for deucravacitinib (Sotyktu) for the treatment of adults with active psoriatic arthritis (PsA) was accepted for review by the US FDA. The drug was assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026 for this indication. This regulatory update comes in addition to the sNDA acceptances by China’s Center for Drug Evaluation of National Medical Products Administration and Japan's Ministry of Health, Labour and Welfare for deucravacitinib for the treatment of adults with active PsA. The company stated the European Medicines Agency has also validated Bristol Myers Squibb's Type II variation application to expand the indication to include this disease. If approved, deucravacitinib found become the first TYK2 inhibitor for the treatment of PsA.¹

“There is a significant need for additional oral treatments for individuals living with PsA, and today’s announcement brings us one step closer to bringing [deucravacitinib] to these patients,” said Roland Chen, MD, senior vice president, Drug Development, Immunology and Cardiovascular, Bristol Myers Squibb, in a news release from the company. “We are eager to continue conversations with the FDA and other global regulatory bodies with the goal of including [deucravacitinib] as a differentiated, first-line, advanced systemic treatment option for PsA, while we pioneer research of this novel molecule in other severe rheumatic conditions.”

In 2022, deucravacitinib received approval from the FDA for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemics or phototherapy.² Since then, the company stated the drug has earned approvals for the same indication across multiple global health authorities and demonstrated durable efficacy as well as a consistent safety profile over more than 20,000 patient-years of experience.

According to the release from Bristol Myers Squibb, these regulatory applications are based on positive results from the POETYK PsA-1 and POETYK PsA-2 trials, which evaluated the efficacy and safety of deucravacitinib in adults with active PsA. The company stated that both trials met their primary endpoint, with a “significantly greater proportion” of deucravacitinib-treated patients achieving ACR20 (at least a 20 percent improvement in signs and symptoms of disease) after 16 weeks of treatment compared with placebo. Additionaklly, data from the POETYK PsA-2 trial reported outcomes through 52 weeks of treatment, demonstrating improved clinical response was maintained from weeks 16 to 52.

The company reported that the safety profile of deucravacitinib through 16 weeks in the POETYK PsA-1 and POETYK PsA-2 trials was consistent with previous studies, with no new safety concerns observed. Initial data from POETYK PsA-2 were presented at the 2025 AAD Annual Meeting, and findings from both trials were shared at the 2025 EULAR Congress, with additional presentations planned.

The phase 3 program evaluated Sotyktu’s efficacy and safety in adults with active PsA.

• POETYK PsA-1 enrolled ~670 biologic-naïve patients.
• POETYK PsA-2 enrolled ~730 patients who were either biologic-naïve or previously treated with TNFα inhibitors.

Both trials had a 52-week duration, including a 16-week placebo-controlled phase followed by active treatment. The primary endpoint for both trials was the ACR20 response at week 16, with several secondary endpoints, including joint damage progression in PsA-1. POETYK PsA-2 also included an apremilast safety reference arm. The company noted patients completing the 52-week treatment in either trial may be eligible for open-label extension studies.

References

1. Bristol Myers Squibb’s supplemental new drug application (sNDA) for sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis accepted for review across four regions globally. News release. BioSpace. Published July 21, 2025. Accessed July 21, 2025. https://www.biospace.com/press-releases/bristol-myers-squibbs-supplemental-new-drug-application-snda-for-sotyktu-deucravacitinib-for-the-treatment-of-adults-with-active-psoriatic-arthritis-accepted-for-review-across-four-regions-globally
2. US Food and Drug Administration approves sotyktu (deucravacitinib), oral treatment for adults with moderate to severe plaque psoriasis. News release. Bristol Myers Squibb. Published September 9, 2022. Accessed July 21, 2025. https://news.bms.com/news/details/2022/U.S.-Food-and-Drug-Administration-Approves-Sotyktu-deucravacitinib-Oral-Treatment-for-Adults-with-Moderate-to-Severe-Plaque-Psoriasis/default.aspx