Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Sotyktu (deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis.
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Sotyktu, an oral medication taken once-daily, is a first-in-class, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.
The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).
The CHMP adopted this positive opinion based on results from the pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 trials, which evaluated once-daily Sotyktu in patients with moderate-to-severe plaque psoriasis versus placebo and twice-daily Otezla (apremilast), as well as an additional two years of data from the POETYK PSO long-term extension trial.
Sotyktu demonstrated significant and clinically meaningful improvements in skin clearance, symptom burden and quality of life measures compared to placebo and Otezla. Sotyktu was well-tolerated with a low rate of discontinuation due to adverse events.
The most common adverse reactions (≥1% of patients on Sotyktu) included upper respiratory infections, herpes simplex infections, oral ulcers, folliculitis and acneiform rash. The results of the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials were published in the Journal of the American Academy of Dermatology.
The U.S. Food and Drug Administration (FDA) approved Sotyktu for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy in September 2022, and Japan's Ministry of Health, Labour and Welfare approved Sotyktu for the treatment of adults with plaque psoriasis, generalized pustular psoriasis, and erythrodermic psoriasis who have had an inadequate response to conventional therapies in September 2022.
In addition to the European Medicines Agency, Sotyktu is also under regulatory review by other health authorities around the world for the treatment of moderate-to-severe plaque psoriasis.
PrOgram to Evaluate the efficacy and safety of Sotyktu (deucravacitinib), a selective TYK2 inhibitor (POETYK) PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) were global Phase 3 studies designed to evaluate the safety and efficacy of Sotyktu compared to placebo and Otezla (apremilast) in patients with moderate-to-severe plaque psoriasis.
Both POETYK PSO-1, which enrolled 666 patients, and POETYK PSO-2, which enrolled 1,020 patients, were multi-center, randomized, double-blind trials that evaluated Sotyktu (6 mg once daily) compared to placebo and Otezla (30 mg twice daily).
POETYK PSO-2 included a randomized withdrawal and retreatment period after Week 24.
The co-primary endpoints of both POETYK PSO-1 and POETYK PSO-2 were the percentage of patients who achieved Psoriasis Area and Severity Index (PASI) 75 response and those who achieved static Physician's Global Assessment (sPGA) score of 0 or 1 (clear/almost clear) at Week 16 versus placebo.
Key secondary endpoints of the trials included the percentage of patients who achieved PASI 75 and sPGA 0/1 compared to Otezla at Week 16 and other measures evaluating Sotyktu versus placebo and Otezla.
Following the 52-week POETYK PSO-1 and POETYK PSO-2 trials, patients could enroll in the ongoing POETYK PSO long-term extension (LTE) trial (NCT04036435) and receive open-label Sotyktu 6 mg once-daily.
1,221 patients enrolled in the LTE trial and received at least one dose of Sotyktu. Efficacy was analyzed utilizing treatment failure rules (TFR) method of imputation, along with sensitivity analyses using modified non-responder imputation and as-observed analysis, which have been used in similar analyses with other agents.
In addition to POETYK PSO-1, POETYK PSO-2 and POETYK PSO-LTE, Bristol Myers Squibb has evaluated Sotyktu in two other Phase 3 studies in psoriasis: POETYK PSO-3 (NCT04167462) and POETYK PSO-4 (NCT03924427). ■