Benzinga | Dec 15, 2021 11:31AM EST

FDA Approves AbbVie's JAK Inhibitor Application For Active Psoriatic Arthritis

The FDA approved AbbVie Inc's (NYSE:ABBV) Rinvoq (upadacitinib; 15 mg) for active psoriatic arthritis (PsA).

* Like Pfizer Inc's (NYSE:PFE) approval for Xeljanz, Rinvoq's approval also covers adult patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

* Earlier this month, the FDA slapped boxed warnings on the labels of Xeljanz, Rinvoq, and Eli Lilly And Co's (NYSE:LLY) Olumiant, flagging the risk of cardiovascular events in high-risk patients who are 50 years and older.

* Rinvoq helped psoriatic arthritis patients treated with 15 mg doses achieve higher ACR50 responses (an improvement of at least 50%) than placebo in two Phase 3 trials.

* In the trials, 38% and 32% of patients on Rinvoq achieved ACR50 responses, compared to 13% and 5% on placebo, respectively.

* The Rinvoq arms also boasted 16% and 9% ACR70 responses, compared to 2% and 1% in the placebo arms, respectively.

* Price Action: ABBV shares are up 1.93% at $129.73 on the last check Wednesday.