AbbVie’s Rinvoq Delay By US FDA Could Foreshadow More Trouble For JAKs
With JAK inhibitors Under A Cloud Of Scrutiny Over Safety, FDA Seeks More Benefit-Risk Data
Executive Summary
The expansion of upadacitinib for a new indication in psoriatic arthritis has been pushed out three months to late in the second quarter.
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FDA Warnings And Restrictions On JAKs Curb Growth Potential Of Big Brands
Pfizer, AbbVie and Lilly will face new safety restrictions on Xeljanz, Rinvoq and Olumiant. Indication expansion remains uncertain, while first-line use appears out of the question.
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.
What Will JAK Inhibitor Safety Jitters Mean For Drug Sales?
Together with a similar delay for AbbVie’s Rinvoq, the delays appear to stem from a study that raised concerns about the class. But the potential sales impact is less clear.