FDA delays review for AbbVie's Rinvoq expanded approval

April 5, 2021

The U.S. FDA has extended the review period for the supplemental NDA for AbbVie's Rinvoq for the treatment atopic dermatitis by three months, citing the need for more time to evaluate AbbVie's updated assessment of the drug's benefit-risk profile.

The Prescription Drug User Fee Act (PDUFA) action date has been extended three months to early Q3 2021.

First approved in 2019 for rheumatoid arthritis, Rinvoq is a JAK inhibitor now being studied in several immune-mediated inflammatory diseases as AbbVie looks to expand the Rinvoq brand in order to diversify revenue streams from its top-selling Humira as the blockbuster nears its patent cliff.

But JAK inhibitors have raised safety concerns and Rinvoq carries a black-box warning on its label, cautioning against increased risk of serious infections, malignancy, and thrombosis. A few weeks ago, the FDA also extended its review on Rinvoq in psoriatic arthritis by three months.

Read the press release