Sotyktu (deucravacitinib) has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.
Rueil-Malmaison, France - 13 août 2023: Siège social France de Bristol-Myers Squibb, entreprise pharmaceutique américaine née de la fusion entre Bristol-Myers Company et Squibb Corporation | Image Credit: © HJBC - stock.adobe.com
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.
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.”
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).
The company entered a global co-development and co-commercialization agreement in June 2025 with BioNTech, a deal valued at up to $11.1 billion, for BNT327, BioNTech’s investigational bispecific antibody targeting programmed death-ligand 1 and vascular endothelial growth factor A (4).
Also in June 2025, Bristol Myers Squibb said it welcomed FDA’s elimination of Risk Evaluation and Mitigation Strategies for seven approved B-cell maturation antigen- and CD19-directed autologous chimeric antigen receptor (CAR)-T cell therapies, saying that “only two in 10 eligible patients receive these potentially transformative therapies due to the confluence of complex logistical and geographic barriers affecting patients and providers,” adding that the regulatory changes could help expand CAR-T use beyond major academic centers to community health settings (5).
In October 2025, Bristol Myers Squibb will be one of the participating organizations at the 15th annual Partnership Opportunities in Drug Delivery (PODD) conference in Boston, and the company’s director of portfolio strategy and integration, Rashmi Thakur, PhD, will be speaking as one of the panelists in a discussion entitled Partnering to Advance Drug Delivery Innovation (6).
1. Bristol Myers Squibb. 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. Press Release. July 21, 2025.
2. Thomas, F. Getting Personal for Blockbusters in 2023. Pharmaceutical Technology 2023, 47 (1) 6.
3. Bristol Myers Squibb. US Food and Drug Administration Approves Opdivo (nivolumab) plus Yervoy (ipilimumab) as a First-Line Treatment for Unresectable or Metastatic Hepatocellular Carcinoma. Press Release. April 11, 2025.
4. Bristol Myers Squibb. BioNTech and Bristol Myers Squibb Announce Global Strategic Partnership to Co-Develop and Co-Commercialize Next-generation Bispecific Antibody Candidate BNT327 Broadly for Multiple Solid Tumor Types. Press Release. June 2, 2025.
5. Cole, C. Biopharm Industry Impacts of FDA Eliminating REMS for CAR-T Therapies. BioPharmInternational.com, June 30, 2025.
6. Cole, C. PODD 2025 Unveils Agenda Highlighting Innovation in Drug Delivery Technologies. PharmTech.com, July 16, 2025.
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