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
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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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.
In this week's podcast version of Five Must-Know Things, hear about new results for Lilly in Alzheimer’s, a US delay for AbbVie, progress for Zolgensma in the UK, challenges for AstraZeneca’s coronavirus vaccine, and a Scrip roundtable on industry lessons from the pandemic.
The US FDA will ponder its regulatory options now that final data are in from a long-term postmarketing study showing tofacitinib is associated with a higher rate of major adverse cardiovascular events and malignancies compared with TNF-inhibitors.