The TYK2 inhibitor showed superior efficacy in improving skin clearance compared to placebo and twice-daily Otezla in the phase 3 POETYK PSO clinical trials


Sotyktu is indicated in the US and the EU for adults with moderate-to-severe plaque psoriasis. (Credit: Bristol-Myers Squibb)

Bristol Myers Squibb has secured approval from the European Commission (EC) for Sotyktu (deucravacitinib) to treat adults with moderate-to-severe plaque psoriasis who are eligible for systemic therapy or phototherapy.

To be administered daily once orally, Sotyktu is a selective, allosteric tyrosine kinase 2 (TYK2) inhibitor.

It is claimed as the first oral therapy with a new mechanism of action approved in almost a decade and the only TYK2 inhibitor approved for any disease in the European Union (EU).

Bristol Myers Squibb chief medical officer Samit Hirawat said: “Today’s approval is a landmark achievement as patients across Europe with moderate-to-severe plaque psoriasis will now have the opportunity to be treated with Sotyktu, the first once-daily oral option to provide significant symptom relief.

“Discovered in our own labs, Sotyktu has a unique mechanism of action and a well-demonstrated safety, efficacy and tolerability profile, representing a potential new oral standard of care, and demonstrating our ability to develop breakthrough, first-in-class treatments with the potential to transform people’s lives.”

The approval was based on the findings from the phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials.

The TYK2 inhibitor showed superior efficacy compared to placebo and twice-daily Otezla (apremilast) at the end of both 16 and 24 weeks in the trials.

Bristol Myers Squibb said that additional data from the POETYK PSO long-term extension trial (LTE) also backed the approval.

The POETYK PSO-1 trial, which enrolled 666 patients, and POETYK PSO-2 trials, which featured 1,020 patients, were global phase 3 studies.

Both the studies were multicentre, randomised, double-blind trials with the objective to assess the efficacy and safety of Sotyktu in comparison to placebo and Otezla.

Last September, Bristol Myers Squibb obtained approval for Sotyktu from the US Food and Drug Administration (FDA) for the treatment of plaque psoriasis in adults. The FDA approval was driven by the findings of the POETYK PSO-1 and POETYK PSO-2 trials.