Bristol Myers Squibb’s Sotyktu Makes Global Regulatory Progress for Psoriatic Arthritis as FDA Accepts sNDA for Review
In a major development for immunology-focused therapeutics, Bristol Myers Squibb (NYSE: BMY) has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib), aimed at treating adults with active psoriatic arthritis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2026, indicating when a regulatory decision on the application is expected.
The FDA’s acceptance of the sNDA follows a series of similar regulatory milestones in other major markets. Regulatory authorities in China, Japan, and the European Union have all accepted corresponding applications for Sotyktu, positioning the drug for potential global label expansion. Specifically, China’s Center for Drug Evaluation under the National Medical Products Administration, Japan’s Ministry of Health, Labour and Welfare, and the European Medicines Agency (EMA) have all initiated formal reviews to evaluate the extension of Sotyktu’s indication to include adult patients with active psoriatic arthritis.
These multi-regional advancements underscore Bristol Myers Squibb’s strategy of expanding access to innovative immunomodulatory treatments in underserved patient populations, and they mark a critical step toward bringing a novel oral therapeutic to individuals living with the burdens of psoriatic arthritis worldwide.
Addressing a High Unmet Need in Psoriatic Arthritis
Psoriatic arthritis is a chronic, inflammatory musculoskeletal disease that affects up to 30% of patients with psoriasis. Characterized by joint pain, stiffness, swelling, and irreversible joint damage if untreated, the disease can lead to significant disability and reduced quality of life. While a variety of biologic and small molecule therapies have been developed to manage psoriatic arthritis, many patients continue to cycle through treatments due to inadequate responses or tolerability issues.
“There is a Bristol Myers 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,” said Dr. Roland Chen, Senior Vice President, Drug Development, Immunology and Cardiovascular at Bristol Myers Squibb.
The potential for Sotyktu to offer a new first-line option with an oral administration route and differentiated mechanism of action could mark a meaningful advance in therapeutic choices. Dr. Chen emphasized the company’s dedication to advancing the development of this molecule across multiple severe immune-mediated inflammatory diseases: “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.”
Background: Sotyktu’s Approved Use and Pharmacological Profile
Sotyktu is an oral, selective tyrosine kinase 2 (TYK2) inhibitor, representing a new class of immunomodulatory agents. The drug was first approved by the FDA in 2022 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. That initial approval marked a breakthrough for TYK2 inhibition in autoimmune diseases, as it was the first therapy of its kind to be cleared by the FDA.
Since its initial U.S. launch, Sotyktu has received marketing approvals from several health authorities globally for the plaque psoriasis indication. Its favorable clinical profile—including durable efficacy and a consistent safety record—has been established across more than 20,000 patient-years of data from global trials and post-marketing experience. With the current regulatory submissions, Sotyktu could become the first TYK2 inhibitor approved for psoriatic arthritis, potentially broadening its reach into a second major immune-mediated inflammatory indication.
Clinical Evidence from POETYK PsA Trials
The Bristol Myers sNDA and corresponding regulatory applications are supported by data from the pivotal POETYK PsA-1 and POETYK PsA-2 trials. These Phase 3 studies assessed the efficacy and safety of Sotyktu in adult patients with active psoriatic arthritis who had an inadequate response to prior therapies.
Both trials met their primary endpoint of ACR20 response at 16 weeks, defined as at least a 20% improvement in the American College of Rheumatology criteria, which measures reductions in joint pain, swelling, and inflammation. In both studies, a significantly higher proportion of patients treated with Sotyktu achieved ACR20 compared with those receiving placebo.
The POETYK PsA-2 trial extended these findings through 52 weeks, demonstrating sustained or even improved clinical responses from Week 16 onward. Key secondary endpoints—such as improvements in physical function, skin clearance, and patient-reported outcomes—were also met, reinforcing the drug’s therapeutic benefit beyond basic disease control.
Safety Profile Consistent Across Indications
Importantly, the Bristol Myers safety profile of Sotyktu in patients with psoriatic arthritis through 16 weeks of treatment remained consistent with prior data from the company’s Phase 2 PsA studies and the Phase 3 trials in plaque psoriasis. No new safety signals emerged in either POETYK PsA-1 or PsA-2, suggesting a favorable risk-benefit profile.
Common adverse events associated with Sotyktu in previous studies have typically included nasopharyngitis, upper respiratory tract infections, and mild to moderate headache or nausea, which are manageable and rarely lead to treatment discontinuation. The absence of significant laboratory abnormalities, including no major changes in liver enzymes, white blood cell counts, or lipid levels, differentiates Sotyktu from other Janus kinase (JAK) inhibitors and supports its TYK2-specific mechanism.
Scientific Presentations and Community Engagement
Bristol Myers Squibb has actively engaged the global scientific and medical communities by presenting detailed findings from its PsA program at key congresses. Early data from the POETYK PsA-2 trial were presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting held in March, highlighting both joint and skin improvements. The full datasets from both POETYK PsA-1 and PsA-2 were subsequently shared at the European Alliance of Associations for Rheumatology (EULAR) Congress in June 2025, where clinicians and researchers responded positively to the efficacy and safety data.
Additional Bristol Myers presentations are planned for upcoming international rheumatology and dermatology conferences throughout 2025 and into early 2026, further showcasing the data to regulatory reviewers, prescribers, and healthcare stakeholders.
Global Opportunity and Strategic Impact
If approved, Sotyktu could become a new oral, non-biologic treatment option for patients with active psoriatic arthritis, potentially as a first-line advanced systemic therapy. This would be particularly impactful for patients who may not tolerate injectable biologics or who prefer oral administration due to convenience, reduced needle anxiety, or cost considerations.
The global regulatory strategy Bristol Myers Squibb is pursuing also reflects the company’s ambition to leverage Sotyktu across multiple autoimmune diseases. Ongoing research is exploring the drug’s utility in lupus, inflammatory bowel disease, and other rheumatologic conditions, with the goal of building a robust portfolio around the TYK2 pathway.
The company extended its gratitude to the investigators and thousands of patients who participated in the clinical development program. “Bristol Myers Squibb thanks the patients and investigators involved in the POETYK PsA clinical trial program,” the company stated.
The FDA’s acceptance of the sNDA for Sotyktu, along with the concurrent submissions under review in China, Japan, and Europe, brings Bristol Myers Squibb closer to offering a new, oral treatment option for the millions of people living with psoriatic arthritis around the world. With compelling clinical data and a mechanism that separates it from existing treatment classes, Sotyktu is positioned as a potential game-changer in the management of psoriatic arthritis and a future cornerstone of Bristol Myers Squibb’s expanding immunology portfolio.
As the March 2026 PDUFA date approaches, the industry will be closely watching how global regulators respond to this novel TYK2 inhibitor—and how its entry into the psoriatic arthritis space might shift current treatment paradigms.
