FDA Delays Decision Over AbbVie’s Rinvoq for Psoriatic Arthritis

The FDA has extended its review period for AbbVie’s supplemental New Drug Application for Rinvoq (upadacitinib) as a treatment for adults with psoriatic arthritis.

The agency’s Prescription Drug User Fee Act-mandated target action date will now be three months later, set for the end of this year’s second quarter.

AbbVie disclosed it had received a recent FDA request for an updated assessment of the drug’s risks and benefits, and that it sent a response, which means the agency “will require additional time for a full review of the submission.”

Rinvoq is well on its way to becoming a blockbuster drug. AbbVie earned $731 million in Rinvoq sales globally in 2020.