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news.Bristol Myers Squibb (BMS) has received the US Food and Drug Administration (FDA) approval for Sotyktu (deucravacitinib), an oral selective tyrosine kinase 2 (TYK2) inhibitor, to treat adults with active psoriatic arthritis (PsA).
Sotyktu has five years of clinical safety and efficacy data in patients with moderate-to-severe plaque psoriasis. Credit: 89stocker / Shutterstock.com.
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This marks the first FDA approval of a TYK2 inhibitor specifically for this indication.
The regulator granted this approval following findings from the pivotal POETYK PsA-I and POETYK PsA-II Phase III studies, which assessed the safety and efficacy of once-daily 6mg Sotyktu in adults with active PsA.
Both trials showed notable improvements in disease activity, with the primary endpoint assessed by the ACR20 and minimal disease activity (MDA) response serving as a key secondary endpoint. Additional endpoints included ACR50 and ACR70.
The most common adverse reactions reported included acne, folliculitis, increased blood creatine phosphokinase, herpes simplex, mouth ulcers, and upper respiratory infections.
The clinical programme included two multi-centre, double-blind, placebo-controlled, randomised studies: POETYK PsA-I with 670 patients who had not previously received biologic disease-modifying antirheumatic drugs, and POETYK PsA-II with 624 patients who were either naïve to such treatments or had been treated with tumour necrosis factor alpha inhibitors.
Both trials included a 52-week treatment period and assessed the proportion of participants achieving an ACR20 response at week 16.
Sotyktu was first approved by the FDA in 2022 for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Since then, global regulatory authorities have granted approvals for this indication. Sotyktu has five years of clinical safety and efficacy data in patients with moderate-to-severe plaque psoriasis.
Bristol Myers Squibb cardiovascular and immunology commercialisation senior vice-president Al Reba said: “Today’s announcement marks the introduction of a new, differentiated option to treat adults with active psoriatic arthritis.
“This latest approval of Sotyktu confirms its important role in managing both skin and joint symptoms of psoriatic disease and is a key milestone as we continue to explore its development in diseases that have limited or no treatment options.”
Last month, BMS reported full-year 2025 revenues of $48.2bn, essentially flat compared with $48.3bn in 2024.
