FDA Approves First TYK2 Inhibitor for Psoriasis

Bristol Myers Squibb announced September 9 that the U.S. Food and Drug Administration (FDA) approved deucravacitinib, a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. is not recommended for use in combination with other potent immunosuppressants.

The approval is based on results from the pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which demonstrated superior efficacy of once-daily deucravacitinib compared to placebo and twice-daily apremilast in 1,684 patients aged 18 years and older with moderate-to-severe plaque psoriasis. The superior efficacy of deucravacitinib compared to placebo and apremilast was demonstrated at both 16 and 24 weeks, and responses with persisted through 52 weeks.

In the POETYK PSO trials, at Week 16, the most common adverse reactions (≥1% and higher than placebo) among patients treated with deucravacitinib were upper respiratory infections, blood creatine phosphokinase increase, herpes simplex, mouth ulcers, folliculitis, and acne.

—Priyam Vora

Reference:
U.S. Food and Drug Administration approves Sotyktu™ (deucravacitinib), oral treatment for adults with moderate-to-severe plaque psoriasis. News release. Bristol Myers Squibb. September 9, 2022. Accessed September 12, 2022. https://news.bms.com/news/details/2022/U.S.-Food-and-Drug-Administration-Approves-Sotyktu-deucravacitinib-Oral-Treatment-for-Adults-with-Moderate-to-Severe-Plaque-Psoriasis/default.aspx