Back when Bristol Myers Squibb acquired Celgene in 2019 for $74 billion, it opted to keep the dermatology and immunology drug deucravacitinib, as opposed to the already-approved Otezla. And now, BMS doesn’t regret this move in the slightest.
Deucravacitinib has won FDA approval for moderate-to-severe plaque psoriasis. And the company believes the drug, now dubbed Sotyktu, could be a new standard of care, Samit Hirawat, the company’s chief medical officer, said in an interview.
“There is no doubt in our minds that this is the right drug,” Hirawat said, especially since the drug has proven to be superior to Otezla, which Amgen now owns. “There’s absolutely no remorse.”
The company is looking to bring Sotyktu to patients within the month, Hirawat added. BMS believes that it has the potential for $4 billion plus in revenue, which the company looks forward to in the back end of the decade, he noted.
One important piece to note with this approval is the lack of a black box warning on Sotyktu, Mizuho analyst Salim Syed wrote to clients on Monday. Combined with Sotyktu’s superior efficacy to Otezla, this could lead to market pressure on Amgen’s Otezla, Syed wrote.
The FDA based its approval on data from the POETYK PSO program. The trials compared the BMS drug at 6 mg once day to placebo and Otezla at 30 mg twice daily. POETYK-PSO-1 enrolled 666 patients, while POETYK PSO-2 included 1,020 patients.
At week 16, 58.7% and 53.6% of patients on Sotyktu achieved a PASI 75 response in the respective trials. That compared with 12.7% and 9.4% for those receiving placebo and 35.1% and 40.2% of patients on Otezla. PASI 75 is a measure on the psoriasis area and severity index.
In other words, the overall skin clearance of those patients was statistically significant and clinically meaningful compared to the placebo and Otezla arms. From a safety perspective, the drug was well tolerated, with a side effect profile that’s “very different” from Otezla’s, said Hirawat. Only about 2.4% of patients discontinued the drug because of serious adverse events, compared to 3.8% in the placebo group and more than 5% in Otezla, he noted.
About 2 million of the 7.5 million people in the U.S. who are affected by psoriasis have moderate-to-severe plaque psoriasis. Usually, the disease starts out in the milder form and patients begin treatment with topical drugs. As the disease progresses, systemic treatments are needed. Today, the drug of choice is Amgen’s Otezla. But physicians want options, according to Hirawat.
Sotyktu is a selective allosteric tyrosine kinase 2 (TYK2) inhibitor, the “first and only selective TYK2 inhibitor in clinical trials across multiple immune-mediated diseases,” a company statement said. The company will read out data from phase 2 programs in Crohn’s disease and ulcerative colitis next year, and it is also being tested in other indications such as psoriatic arthritis and lupus erythematosus.