Adding to regulatory approvals in the USA and European Union, US pharma major Bristol Myers Squibb (NYSE: BMY) said today that its first drug in psoriasis, Sotyktu (deucravacitinib), has been granted Marketing Authorisation (MA) in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA).
The MA was based on pivotal data from the Phase III POETYK PSO-1 and POETYK PSO-2 clinical trials, which demonstrated deucravacitinib’s superior efficacy and ability to improve skin condition and symptoms compared to a placebo (primary endpoint) and apremilast (secondary endpoint) in adult patients with moderate to severe plaque psoriasis.
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