First-in-class plaque psoriasis oral therapy approved in EU

The European Commission (EC) has approved Sotyktu (deucravacitinib), a first-in-class, allosteric tyrosine kinase 2 (TYK2) inhibitor for adults with moderate-to-severe plaque psoriasis. The oral treatment is indicated for patients who are candidates for systemic therapy.

Bristol Myers Squibb’s TYK2 inhibitor

Sotyktu is the first oral therapy with a new mechanism of action approved in nearly 10 years for moderate-to-severe plaque psoriasis. Therefore, it represents a new class of small molecules.

Dr Samit Hirawat, Chief Medical Officer of Bristol Myers Squibb stated the EU approval is a “landmark achievement”. It is the only TYK2 inhibitor approved for the treatment of any disease in the EU.

Sotyktu targets TYK2 and inhibits the signalling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN). These are key cytokines involved in the pathogenesis of multiple immune-mediated diseases. At therapeutic doses, Sotyktu does not inhibit Janus kinase (JAK)1, JAK2 or JAK3.

Patients now have “a tolerable, highly efficacious, once-daily oral treatment option that does not require lab monitoring,” explained Dr Diamant Thaçi, PhD, Director and Professor at the Institute and Comprehensive Center for Inflammation Medicine, University Lübeck, Germany.

Data that supported the approval

EC’s approval was based on results from Bristol Myers Squibb’s Phase III POETYK PSO-1 and POETYK PSO-2 clinical trials. Once-daily treatment of Sotyktu demonstrated superior efficacy compared to placebo and twice-daily Otezla^® (apremilast). These results were observed both at 16 and 24 weeks, with responses maintained through 52 weeks.

“The Phase III POETYK-PSO clinical trials showed that Sotyktu demonstrated significant, durable efficacy across multiple key endpoints, including skin clearance and symptom burden,” added Dr Thaçi.

The POETYK PSO-1 trial enrolled 666 patients. POETYK PSO-2 evaluated 1,020 patients. In both studies, Sotyktu was given as 6mg once daily compared to placebo. Dosage for Otezla was 30mg twice daily.