FDA Clears Bristol Myers Squibb's Sotyktu as First TYK2 Drug for Psoriatic Arthritis

Bristol Myers Squibb secured FDA approval to expand Sotyktu's label to cover active psoriatic arthritis, making the oral drug the first and only tyrosine kinase 2 inhibitor authorized for the joint-and-skin condition and opening a new competitive front in a market long dominated by rival Amgen's Otezla.

The approval, announced March 6, adds psoriatic arthritis to Sotyktu's existing indication for moderate-to-severe plaque psoriasis, which the FDA first cleared in 2022. Psoriatic arthritis affects an estimated 30 percent of people with psoriasis, causing painful joint inflammation alongside skin symptoms, and patients often cycle through multiple therapies before finding adequate relief.

The regulatory green light rests on results from two pivotal Phase 3 studies, POETYK PsA-1 and POETYK PsA-2, which tested deucravacitinib at 6 mg once daily. Significantly more patients receiving Sotyktu achieved an ACR20 response, the standard measure of at least 20 percent improvement in joint disease activity, compared with placebo at Week 16. Minimal Disease Activity, a more stringent benchmark that captures near-remission status, served as a key secondary endpoint and also favored the drug.

"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," said Al Reba, senior vice president of cardiovascular and immunology commercialization at Bristol Myers Squibb.

The indication broadens the commercial case for a drug that has grown steadily but has yet to reach blockbuster scale. Sotyktu generated $291 million in sales in 2025, up from $246 million in 2024, according to company figures, a trajectory that contrasts with the rapid rise of BMS stablemates Opdualag and Camzyos, which each cleared $1 billion in annual sales. Psoriatic arthritis access to a larger patient population could accelerate that trajectory.

The competitive timing is notable. Otezla, Amgen's oral psoriatic arthritis standard-bearer, posted $1.8 billion in 2025 sales, down from a five-year range of $2.1 billion to $2.3 billion, and faces IRA Medicare price negotiation pressure starting next year. Sotyktu's distinct mechanism, selectively blocking TYK2, a signaling enzyme implicated in the inflammatory pathways driving both psoriasis and psoriatic arthritis, rather than broadly suppressing the immune system, could appeal to physicians and patients seeking a more targeted oral option.

Sotyktu traces its origins to BMS's $74 billion acquisition of Celgene in 2019, one of the largest pharmaceutical mergers in history. The drug has taken longer than some analysts expected to build commercial momentum, but the expanded label positions it as a potential dual-indication asset capable of addressing the full spectrum of psoriatic disease in a single pill.

Psoriatic arthritis has no cure, and roughly 40 percent of patients on existing therapies do not achieve adequate disease control. For that population, the arrival of the first approved TYK2-targeted option represents a meaningful addition to the treatment toolkit, though the full efficacy magnitude and long-term safety profile from the POETYK trials will shape how broadly rheumatologists adopt it in practice.