FDA Approves Sotyktu™ for Psoriasis

On September 9, 2022, the U.S. Food and Drug Administration (FDA) approved Sotyktu™ (deucravacitinib), an oral treatment for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sotyktu™ is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor. [1]

"Deucravacitinib is a once-daily oral medication with its clinical trials in moderate-to-severe psoriasis demonstrating superior efficacy to apremilast. Deucravacitinib works by selectively inhibiting TYK2, a protein found in immune cells and shown to be central to what causes psoriasis. This medication offers patients with psoriasis who are appropriate for systemic therapy a brand-new option that has very few side effects. Importantly, the results from the studies don’t support the need to follow laboratory tests during therapy," shared Bruce Strober, M.D., Ph.D., a clinical professor in the department of dermatology at Yale University School of Medicine in New Haven, Connecticut, and a board-certified dermatologist at Central Connecticut Dermatology Research in Cromwell, Connecticut.

The approval of Sotyktu™ is based on Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials. During the trials, Sotyktu™ demonstrated superior efficacy at both 16 and 24 weeks compared to placebo and another treatment. Efficacy persisted through 52 weeks. [1]

“The last two decades have seen one breakthrough after another in the development of new biologics, all injectable, for psoriasis. Deucravacitinib's approval is a major milestone for those of us treating psoriasis as the drug has clinical efficacy comparable to biologics but is safer than older drugs used for psoriasis,” says Mark Lebwohl, M.D., the dean for clinical therapeutics at Icahn School of Medicine at Mount Sinai’s Kimberly and Eric J. Waldman Department of Dermatology, New York.

Sotyktu™ is expected to be available to patients in the U.S. starting in September 2022. [1]