BMS receives FDA approval for Sotyktu for psoriatic arthritis

The FDA approved Sotyktu (deucravacitinib), an oral TYK2 inhibitor, to treat adults with active psoriatic arthritis after positive results from the Phase III POETYK PsA-I and POETYK PsA-II trials.

Bristol Myers Squibb (BMS) announced that the US Food and Drug Administration has approved Sotyktu (deucravacitinib) to treat adults with active psoriatic arthritis. Sotyktu is an oral selective tyrosine kinase 2 (TYK2) inhibitor. This marks the first FDA approval of a TYK2 inhibitor specifically for this indication. The approval was based on data from the Phase III POETYK PsA-I and POETYK PsA-II clinical trials. Key facts: - The approval follows two multi-centre, double-blind, placebo-controlled Phase III studies: POETYK PsA-I (670 patients) and POETYK PsA-II (624 patients). - Both trials assessed once-daily 6 mg Sotyktu over a 52-week treatment period and measured the proportion of participants achieving an ACR20 response at week 16; minimal disease activity (MDA) was a key secondary endpoint. - Additional efficacy endpoints reported included ACR50 and ACR70 responses. - The most common adverse reactions observed included acne, folliculitis, increased creatine phosphokinase, herpes simplex, mouth ulcers, and upper respiratory infections. - Sotyktu was first approved by the FDA in 2022 for moderate-to-severe plaque psoriasis and has five years of clinical safety and efficacy data in that population. Summary: The approval adds an FDA-authorised treatment option for adults with active psoriatic arthritis and is the first TYK2 inhibitor cleared for this use. Bristol Myers Squibb stated it will continue to explore Sotyktu's development in other psoriatic disease areas. Broader regulatory or clinical milestones beyond this announcement were not specified.