FDA approves Sotyktu for psoriasis
Click Here to Manage Email Alerts
Bristol Myers Squibb’s deucravacitinib was approved by the FDA for the treatment of moderate to severe plaque psoriasis, the company announced in a press release.
Sotyktu (deucravacitinib) is an oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor.
“This really broadens not only the number of treatments we have, but the way we can treat patients,” Mark G. Lebwohl, MD, dean of clinical therapeutics and chair emeritus of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai and one of the trial investigators, told Healio. “Having an oral medication that is as effective as a biologic is a major breakthrough.”
The approval was based on data from the phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which compared a daily 6 mg dose of Sotyktu with both placebo and twice-daily Otezla (apremilast).
After 24 weeks of treatment in the trials, 69% and 58% of patients treated with Sotyktu achieved PASI 75, compared with 38% of those in each Otezla arm. Also, 42% and 32% achieved PASI 90, compared with 22% and 20% of those in the Otezla cohorts.
“The approval of Sotyktu represents an exciting day for patients suffering from moderate to severe plaque psoriasis who are not satisfied with topical and conventional treatments,” Samit Hirawat, MD, chief medical officer of Bristol Myers Squibb, said in the release. “This is another extraordinary achievement for Bristol Myers Squibb, as we bring forward a new mechanism of action, the first oral treatment approved in nearly 10 years, and the first orally dosed once-daily treatment for moderate to severe plaque psoriasis.”