Shots:

• The US FDA has accepted the NDA & EMA has validated the MAA for deucravacitinib to treat PsO with an anticipated PDUFA date is Sept 10, 2022
• The application is based on the P-III POETYK PSO-1 & 2 trials to evaluate deucravacitinib (qd) vs PBO & Otezla in 666 & 1,020 patients with PsO that showed improvements in skin clearance, symptom burden & QoL, well-tolerated with a low rate of discontinuation due to AEs & no lab abnormalities were observed
• Deucravacitinib is an oral, selective TYK2 inhibitor & is being studied in multiple immune-mediated diseases including PsO, PsA, lupus & IBD. The therapy is being evaluated in 3 other P-III studies in PsO i.e., POETYK PSO-3/4 & POETYK PSO-LTE

Ref: BMS | Image: BMS