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FDA Approves ORAL Tx for Plaque Psoriasis- Sotyktu

The FDA recently approved a new first-in-class tyrosine kinase 2 (Tyk2) inhibitor, ORAL therapy, Sotyktu (deucravacitinib) from Bristol Myers Squibb, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The approval included a favorable safety profile.

Sotyktu joins a robust multi-$- billion plaque psoriasis market with analysts suggesting that it will rapidly break $4 billion at peak. By reference, Amgen’s Otelza, clipped in with $2.3 billion in 2021 and is also an oral….. but with twice daily dosing. Trial results demonstrated a significant uptick in patient response with Sotyktu vs. Otezla. Competing injectable drugs include Cosentyx (secukinumab) and Skyrizi (risankizumab). There are an estimated eight million people diagnosed with plaque psoriasis in the US. 

BMS confirmed that Sotyktu will launch at a price of $6,164 for a 30-day supply (approx. 40% higher than Otezla.

BMS did not announce plans for distribution. Given the relatively large patient population and relatively low therapy management requirements there is little justification for BMS to launch Sotyktu in limited distribution. However, BMS has gone the LD route for other oral specialty therapies in the past….. and….. Otezla launched through LD. So, SPs must wait to see if Sotyktu will be one of the few newly approved drugs that they can add to their toolbox.

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