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Sotyktu
Sotyktu (deucravacitinib) was approved for the following therapeutic use:
Sotyktu is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Deucravacitinib is a small molecule that selectively inhibits the tyrosine kinase 2 (TYK2) enzyme. Deucravacitinib binds to the regulatory domain of TYK2, stabilising an inhibitory interaction between the regulatory and the catalytic domains of the enzyme. This results in allosteric inhibition of receptor-mediated activation of TYK2 and its downstream functions in cells. TYK2 is a member of the Janus kinase (JAK) family. JAK kinases, including TYK2, function in pairs to mediate Janus kinase-signal transducer and activator of transcription [JAK-STAT] pathways. TYK2 pairs with JAK1 to mediate multiple cytokine pathways and also pairs with JAK2 to transmit signals. The pairing of TYK2 with either JAK1 or JAK2 mediates signalling of a narrower range of cytokines compared with the pairings of JAKs 1/2/3 with each other. The allosteric mechanism of action of deucravacitinib has been shown to inhibit TYK2 with minimal or no inhibition of JAK 1/2/3. TYK2 mediates signalling of interleukin-23 (IL-23) cytokine, interleukin-12 (IL-12) cytokine, and type I interferons (IFN), which are naturally occurring cytokines involved in inflammatory and immune responses. Deucravacitinib inhibits signalling from IL-23, IL-12 and type I IFN and the downstream release of proinflammatory cytokines and chemokines.
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Sotyktu was considered favourable for the therapeutic use approved.