Bristol Myers' Sotyktu sNDA accepted for review by FDA

Bristol Myers' Sotyktu sNDA accepted for review by FDA

Bristol Myers Squibb (NYSE: BMY) has achieved a significant regulatory milestone as the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026 [1].

This acceptance follows positive results from the pivotal Phase 3 POETYK PsA-1 and POETYK PsA-2 clinical trials, which demonstrated that significantly more patients treated with Sotyktu achieved an ACR20 response compared to placebo at Week 16. The sNDA acceptance by the FDA is in addition to previous approvals by China’s Center for Drug Evaluation and Japan's Ministry of Health, Labour and Welfare for Sotyktu for the treatment of adults with active psoriatic arthritis [1].

Sotyktu, an oral, selective TYK2 inhibitor, has the potential to be the first TYK2 inhibitor for the treatment of psoriatic arthritis. The drug received FDA approval in 2022 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Since then, it has earned approvals for this indication from multiple global health authorities and demonstrated durable efficacy and a consistent safety profile over more than 20,000 patient-years of experience [1].

Bristol Myers Squibb's Senior Vice President, Roland Chen, MD, stated, "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." The company is eager to continue conversations with the FDA and other global regulatory bodies to include Sotyktu as a differentiated, first-line, advanced systemic treatment option for psoriatic arthritis [1].

References:
[1] https://www.morningstar.com/news/business-wire/20250717182422/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