The US Food and Drug Administration (FDA) has authorized deucravacitinib, an oral selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of people with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, the producer reported on September 9.

According to Bristol Myers Squibb (BMS), deucravacitinib, this will be sold under the brand name Sotyktu and is the first medication in this class to receive approval.

The FDA approved based on the findings of two phase 3 trials POETYK PSO-1 and POETYK PSO-2 involving almost 1700 adults with moderate to severe plaque psoriasis. The company claims that when compared to placebo and apremilast (Otezla), once-daily deucravacitinib treatment significantly and clinically improved skin clearance and symptoms.

Patients in the two studies were randomized to receive apremilast (30 mg twice day), a placebo, or deucravacitinib (6 mg daily). At 16 weeks, deucravacitinib-treated patients achieved a PASI 75 response at rates of 58% and 53%, respectively, in the POETYK PSO-1 and POETYK PSO-2 studies, as compared to placebo at rates of 13% and 9%, and apremilast-treated patient at rates of 35% and 40% , in the POETYK PSO-1 and POETYK PSO-2 studies respectively.

After 16 weeks of treatment with deucravacitinib only 1% patients reported some adverse events. Further, 2.4% of persons receiving deucravacitinib , 5.2% of those receiving apremilast, and 3.8% in the placebo group showed adverse events resulting from treatment discontinuation.

Clinical trials using deucravacitinib are also being conducted for lupus, psoriatic arthritis, and inflammatory bowel disease. According to BMS, it is not advised to be used in conjunction with other potent immunosuppressant. (Medscape - Sep 12, 2022)