European Commission approves Sotyktu for adults with moderate to severe plaque psoriasis

Key takeaways:

• Sotyktu is now the only tyrosine kinase 2 inhibitor approved for the treatment of any disease in the European Union.
• The approval was supported by positive results from a phase 3 trial.

The European Commission has approved Sotyktu in the European Union for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, Bristol Myers Squibb announced in a press release.

This approval, which follows the European Medicines Agency’s recommendation in January, makes Sotyktu (deucravacitinib), a first-in-class, selective tyrosine kinase 2 inhibitor, the first oral therapy with a new mechanism of action to be approved in nearly 10 years in this indication.

The European Commission’s decision was supported by results from the phase 3 POETYK PSO-1 and POETYK PSO-2 trials where Sotyktu demonstrated superior efficacy compared with placebo and twice-daily Otezla (apremilast, Celgene).

Results showed that the drug outperformed its counterparts at both 16 and 24 weeks in skin clearance and symptom burden, with efficacy being maintained through week 52.

“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,” Samit Hirawat, MD, executive vice president and chief medical officer of drug development, Bristol Myers Squibb, said in the release.