AbbVie Seeks Rinvoq Approval For Psoriatic Arthritis In US, Europe

Drugmaker AbbVie (ABBV) has announced that it has submitted applications for a new indication for Rinvoq (upadacitinib; 15 mg, once daily) for the treatment of adult patients with active psoriatic arthritis.

The applications were submitted to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

“Psoriatic arthritis is a complex heterogeneous disease with manifestations across multiple domains, including joints and skin, causing daily pain, fatigue and stiffness,” said Michael Severino of AbbVie. “We look forward to working with regulatory authorities and hope to bring RINVOQ to people living with this debilitating disease as quickly as possible.”

The applications are supported by data from two Phase 3 studies across a broad range of more than 2,000 patients with active psoriatic arthritis. In both studies, Rinvoq, a selective and reversible JAK inhibitor, met the primary endpoint of ACR20 response at week 12 versus placebo. It also achieved non-inferiority versus adalimumab in terms of ACR20 response at week 12.

Overall, the safety profile of the treatment in psoriatic arthritis was consistent with previously reported results across the Phase 3 rheumatoid arthritis clinical trial program, with no new significant safety risks detected.

In 2019, Rinvoq received both US and European approval for adult patients with moderately to severely active rheumatoid arthritis. Meanwhile Phase 3 trials of Rinvoq are ongoing for a number of other diseases including axial spondyloarthritis, Crohn’s disease, atopic dermatitis, ulcerative colitis and giant cell arteritis.

Overall, Wall Street analysts are upbeat about the prospects for AbbVie. In a review of 9 analysts, the stock scores 7 Buys and the rest are Holds adding up to a Strong Buy consensus. The $102.29 average price target indicates 13% upside potential in the coming 12 months. Shares are currently trading up 2.5% year-to-date. (See Abbvie’s stock analysis on TipRanks).

“Our investment thesis on AbbVie is based on our view that ABBV will generate double-digit near-term growth on the back of P&L catch-up in 2021 and strength of core franchises” says RBC Capital’s Randall Stanicky, as he reiterated his buy rating while bumping his price target to $102 from $98 on May 26.

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