Rinvoq Shows Strong UC Efficacy, But Will JAK Ghosts Haunt It?
Safety appears balanced between the drug and placebo arms in upadacitinib’s third Phase III trial in ulcerative colitis, but there were low numbers of MACE and there are lingering safety concerns about the JAK class overall.
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The company plans to release topline results this year in ulcerative colitis and pulmonary arterial hypertension. In UC, especially, Gossamer is aiming for an opportunity that remains untapped.
A safety-related FDA revision of Rinvoq’s label in rheumatoid arthritis is a perceived threat to the JAK inhibitor’s growth, but it and fellow immunology asset Skyrizi produced another strong sales quarter.
Top-line results from a Phase IIb study of Theravance’s potential gut-selective JAK inhibitor izencitinib have not matched expectations, and results from a similar early-stage study in Crohn’s disease with the Janssen-partnered candidate are now awaited at the end of the year or in early 2022.