Bristol Myers Seeks Expanded Approval for Sotyktu in Active Psoriatic Arthritis

Bristol Myers Squibb announced that the FDA has accepted its application to expand approval of Sotyktu for active psoriatic arthritis treatment. The FDA has assigned a target action date of March 6, 2026, for a decision. Regulatory authorities in Europe, China, and Japan are also reviewing Sotyktu for expanded approval. Sotyktu is currently approved for adults with moderate-to-severe plaque psoriasis and reported 2024 sales of $246 million, up 45% over the previous year.

Bristol Myers Squibb (NYSE: BMY) has made significant progress in its efforts to expand the approval of Sotyktu (deucravacitinib) for the treatment of active psoriatic arthritis (PsA). On July 21, 2025, the U.S. Food and Drug Administration (FDA) accepted for review the company's supplemental New Drug Application (sNDA) for Sotyktu. The FDA has assigned a target action date of March 6, 2026, for a decision [1].

Sotyktu, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, has already demonstrated promising results in clinical trials. The pivotal Phase 3 POETYK PsA-1 and POETYK PsA-2 trials showed that significantly more patients treated with Sotyktu achieved an ACR20 response compared to placebo at Week 16. The FDA's decision to accept the sNDA for review follows positive clinical trial results, which highlight the drug's potential as a first-line, advanced systemic treatment option for PsA [1].

Bristol Myers Squibb's regulatory efforts are not limited to the U.S. The company has also received sNDA acceptances from China’s Center for Drug Evaluation of National Medical Products Administration and Japan's Ministry of Health, Labour and Welfare for Sotyktu. Additionally, the European Medicines Agency has validated a Type II variation application to expand the indication for Sotyktu to include PsA [1].

Sotyktu is currently approved for adults with moderate-to-severe plaque psoriasis and has reported 2024 sales of $246 million, up 45% over the previous year. The expansion of Sotyktu's approval to include PsA could further boost Bristol Myers Squibb's financial performance by tapping into a new market segment [1].

References:

[1] https://news.bms.com/news/corporate-financial/2025/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/default.aspx