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Sareum Holdings PLC on Monday said the US Food & Drug Administration has approved 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.’
Shares in Sareum were up 0.3% to 160.50 pence each in London on Monday midday.
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