In a whirlwind seven-month period in 2022, Bristol-Myers Squibb received FDA approval for three new products, each touting the potential for peak sales of $4 billion.
Opdualag, a treatment for multiple myeloma, and Camjos, a treatment for cardiomyopathy, were big hits last year, but Sotiktu, a treatment for psoriasis, was not as successful.
But the new FDA approval for Sotiktu allows BMS to bring the oral drug it acquired in its $74 billion acquisition of Celgene in 2019 to more patients.
U.S. regulators have approved Sotiktu as a treatment for adults with active psoriatic arthritis. This is the first drug in its class as a selective allosteric tyrosine kinase 2 (TYK2) inhibitor approved for this indication. This positive review comes in addition to Sotyktu’s initial FDA approval for moderate to severe plaque psoriasis.
“This approval of Sotyktu confirms Sotyktu’s important role in managing both the skin and joint symptoms of psoriasis and is an important milestone as we continue to explore the development of Sotyktu in diseases where there are limited or no treatment options,” Al Reba, the company’s commercial director of cardiovascular and immunology, said in the release.
This blessing is supported by data from two trials showing that 54% of patients receiving 6 mg of Sotiktu per day achieved a 20% improvement in disease activity at week 16, compared with 39% in the placebo group in one trial and 34% in the placebo group in the other trial.
When measuring a 50% improvement in disease symptoms, 24% and 29% of those in the Sotiktu group achieved that rating, compared with 14% and 16% in the placebo group.
“Psoriatic arthritis is a chronic, progressive autoimmune disease that often affects both the joints and skin. Patients often have difficulty moving and being active and may experience pain in their joints, tendons, and ligaments,” added Philip Mies, M.D., director of rheumatology research at Sweden Providence Medical Center, in the release. “New oral, effective first-line treatments are needed.”
Takeda is preparing a new oral competitor using the TYK2 inhibitor zasocitinib. The Japanese company paid Nimbus Therapeutics $4 billion to acquire the compound. The compound has been successful in two phase 3 trials in plaque psoriasis, and regulatory filings are expected this year.
Another competitor is developing Johnson & Johnson’s IL-23 inhibitor icotrokinra, which outperformed Sotokitu on secondary endpoints in two Phase 3 psoriasis trials. J&J’s partner Protagonist Therapeutics originally developed the oral peptide.
In 2019, BMS made a big bet on Sotiktou, deciding to keep its then-pipeline assets despite putting its acquisition of Celgene on hold. Under the decision, BMS sold the blockbuster Otezla to Amgen for $13.4 billion to resolve antitrust concerns surrounding the Celgene merger.
Otezla’s sales were between $2.1 billion and $2.3 billion for five consecutive years, but Amgen announced that sales had fallen to $1.8 billion in 2025. Otezla will become eligible for IRA Medicare pricing early next year.
BMS reported that Sotyktu’s sales last year were $291 million, while 2024 sales were $246 million. Opduaragu, on the other hand, generated $1.2 billion in sales and Kamjos achieved $1.1 billion in 2025. Kamjos was acquired by BMS in 2020 when it acquired MyoKardia for $13.1.
