Last checked at 
(Correcting that Bristol-Myers gained US FDA approval, not Sareum.)
(Alliance News) - Sareum Holdings PLC on Monday noted that the US Food & Drug Administration has approved Bristol-Myers Squibb Co's Sotyktu, a first-in-class, oral, selective, allosteric tyrosine kinase 2 inhibitor.
Sareum is a Cambridge, England-based drug developer for cancer and autoimmune diseases.
The company said that Sotyktu is for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The US FDA approval is based on a pivotal Phase 3 study of deucravacitinib which demonstrated "superior efficacy" against placebo and standard of care. Deucravacitinib was "well tolerated" in the Phase 3 study, Sareum added.
The company said that the approval provides clinical validation for the broader TYK2/JAK1 signalling family, which underpins its clinical portfolio.
Chief Executive Tim Mitchell said: "We're encouraged that the FDA has approved Sotyktu. We believe this validates the potential of this new therapeutic class and supports our own growing confidence around our lead programme and our broader portfolio of TYK2/JAK1 inhibitors."
By Sophie Rose; sophierose@alliancenews.com
Copyright 2022 Alliance News Limited. All Rights Reserved.
