In a dizzying span of seven months in 2022, Bristol Myers Squibb gained FDA approval for three new products, touting each with the potential to achieve $4 billion in peak sales.
While multiple myeloma drug Opdualag and cardiomyopathy treatment Camzyos became blockbusters last year, psoriasis med Sotyktu wasn’t close.
With a new FDA nod in hand for Sotyktu, however, BMS can reach more patients with the oral med, which was acquired in the drugmaker’s 2019 buyout of Celgene for $74 billion.
The U.S. regulator has endorsed Sotyktu as a treatment for adults with active psoriatic arthritis. It becomes the first drug in its class as a selective allosteric tyrosine kinase 2 (TYK2) inhibitor to be approved in the indication. The thumbs up comes on top of Sotyktu’s original FDA approval for moderate-to-severe plaque psoriasis.
“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,” Al Reba, the company’s commercial lead in cardiovascular and immunology, said in a release.
The blessing is backed by data from two trials showing that 54% of patients on a daily 6 mg dose of Sotyktu achieved a 20% improvement in disease activity at Week 16, compared with 39% on placebo in one study and 34% on placebo in the other trial.
When the measurement was 50% improvement in disease symptoms, 24% and 29% of those on Sotyktu made the grade, compared to 14% and 16% of those on placebo.
“Psoriatic arthritis is a chronic, progressive autoimmune condition that often involves both the joints and skin. Patients often have trouble moving and staying active and can experience pain in the joints, and tendons, or ligaments,” Philip Mease, M.D., the director of rheumatology research at Providence Swedish Medical Center, added in a release. “New oral, effective first-line treatments are needed.”
A new oral competition is on its way from Takeda, with its TYK2 inhibitor zasocitinib. The Japanese company paid $4 billion to Nimbus Therapeutics to acquire the compound, which has achieved success in two phase 3 trials in plaque psoriasis and is lined up for regulatory filings this year.
Another competitor is on its way with Johnson & Johnson’s IL-23 inhibitor icotrokinra, which has topped Sotkytu as secondary endpoints in two psoriasis phase 3 studies. J&J’s partner, Protagonist Therapeutics, originally developed the oral peptide.
In 2019, BMS made a big bet on Sotyktu by deciding to keep the then-pipeline asset despite its pending acquisition of Celgene. Based on that decision, BMS sold its mega-blockbuster Otezla to Amgen for $13.4 billion to resolve antitrust concerns surrounding the Celgene merger.
After five straight years of Otezla sales between $2.1 billion and $2.3 billion, Amgen said that they dropped to $1.8 billion in 2025. Otezla will be subject to IRA Medicare pricing at the start of next year.
BMS reported sales of $291 million for Sotyktu last year compared to $246 million in 2024. Meanwhile, Opdualag generated $1.2 billion in sales and Camzyos achieved $1.1 billion in 2025. Camzyos was gained by BMS in a $13.1 buyout of MyoKardia in 2020.