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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

 
• By Mandy Jackson

The expansion of upadacitinib for a new indication in psoriatic arthritis has been pushed out three months to late in the second quarter.

Paper plane gets stuck in metal fence
High-flying Rinvoq's ascent may be stalled by psoriatic arthritis approval delay • Source: Shutterstock

The US Food and Drug Administration has pushed the decision date on a second indication for AbbVie Inc.'s for Rinvoq out three months to late in the second quarter of 2021 to review additional safety data for the JAK1 inhibitor, the company said on 17 March. The delay and new scrutiny put future revenue potential at risk for a drug AbbVie is relying on to help offset Humira sales declines.

AbbVie executives emphasized during the company’s fourth quarter earnings call in early February that new safety concerns for Pfizer Inc.’s market-leading JAK inhibitor Xeljanz (tofacitinib) were not likely to extend to Rinvoq (upadacitinib), which was approved in the US for rheumatoid arthritis in 2019. (Also see "AbbVie’s Post-Humira Strategy Continues Taking Shape With Rinvoq Approval" - Scrip, 16 August, 2019

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