FDA Approves Sotyktu from BMS for Adults with Moderate-to-Severe Plaque Psoriasis

The FDA has granted approval to Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The oral drug binds to tyrosine kinase 2 (TYK2), an intracellular enzyme that mediates immune signaling and inflammatory signaling pathways. The drug stabilizes an inhibitory interaction between the regulatory and the catalytic domains of the enzyme, the company said.

The agency approval is based on results from two phase 3 clinical trials, with the drug demonstrating superior efficacy compared to placebo and Amgen’s Otezla (apremilast).

However, Sotyktu is not recommended for use in combination with other potent immunosuppressants.