Bristol Myers Squibb (BMS) recently announced the European Commission approval for Sotyktu (deucravacitinib), its first-in-class, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor for adults with moderate-to-severe plaque psoriasis (PsO). Representing a new class of small molecules with a unique mechanism of action, Sotyktu is set to become a blockbuster for the treatment of PsO with a global sales forecast of $2.9 billion by 2029, according to GlobalData, a leading data and analytics company.

Mariam Shwea, Healthcare Analyst at GlobalData, comments: “BMS’s Sotyktu is hailed as a landmark achievement for the treatment of moderate-to-severe PsO due to the prior absence of a much-needed once-daily, symptom relieving, and tolerable therapeutic alternative in Europe, where this chronic and systemic inflammatory dermatological condition has the highest prevalence globally.”

The European Commission’s approval of Sotyktu was based on results from BMS’s global, randomized, double-blind Phase III POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) clinical trials, which exhibited superior efficacy of deucravacitinib compared to a placebo and Amgen’s oral apremilast (Otezla), its direct competitor, at weeks 16 and 24, with responses maintained over a period of 52 weeks.

Shwea adds: “In contrast to its main competitors, Sotyktu’s TYK2 mechanism of action does not inhibit Janus kinase (JAK) 1, 2, or 3, and it has not yet been established whether it may be associated with the observed or potential adverse reactions of JAK inhibition.”

Further data points from the POETYK PSO long-term extension trial (LTE) (NCT04036435), in which patients could enroll after PSO-1 and 2, reinforced the European nod after a consistent safety profile in patients following a continuous treatment duration of three years with the open-label Sotyktu 6mg PsO drug.

Shwea concludes: “Despite the inhibition of TYK2 potentially affecting a smaller number of inflammatory cytokine pathways when compared to other JAK inhibitors, Sotyktu’s safety and tolerability profile needs continuous monitoring due to a lack of long-term data beyond three years to eventually become a blockbuster and potentially a new standard-of-care for the oral treatment of PsO, as well as directly competing against formidable and established biologics in the space, including AbbVie’s highly acclaimed Skyrizi.”