AbbVie Scores FDA Approval For Its Blockbuster Drug Rinvoq To Treat Type Of Arthritis

The U.S. Food and Drug Administration on Tuesday approved AbbVie Inc.’s ABBV Rinvoq (upadacitinib), 15 mg, once daily, for giant cell arteritis (GCA).

GCA is an inflammation of blood vessels, called arteries, in and around the scalp.

Earlier in April, the European Commission approved Rinvoq for giant cell arteritis in adult patients.

• Rinvoq is the first and only oral JAK inhibitor approved in the EU,  Iceland, Liechtenstein and Norway for adult patients with GCA.

The approvals are supported by the pivotal Phase 3 SELECT-GCA clinical trial results, which met the primary endpoint of sustained remission.

• 46.4% of patients receiving Rinvoq 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission from week 12 to week 52, compared to 29.0% of patients receiving placebo in combination with a 52-week steroid taper regimen; p=0.002.

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On Friday, AbbVie reported an adjusted EPS of $2.46, up 6.5% year over year and beating the consensus of $2.38.

• The pharmaceutical giant reported sales of $13.34 billion, up 8.4% on a reported basis (+9.8% on an operational basis), beating the consensus of $12.92 billion.
• It reported adjusted earnings per share of $2.46, beating the street view of $2.38.
• In the first quarter of 2025, Rinvoq sales reached $1.72 billion, an increase of 57.2% (+59.7%).
• BMO Capital Markets on Monday wrote that every quarter seems to tell the same story. Analysts think they've accurately factored in Skyrizi and Rinvoq's growth, only for AbbVie to outperform expectations once again.

Last Thursday, AbbVie submitted a Biologics License Application to the FDA for trenibotulinumtoxinE (TrenibotE) for moderate to severe glabellar lines (commonly known as frown lines).

• TrenibotE is a first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as eight hours after administration (earliest assessment time) and a shorter duration of effect of two to three weeks. 

ABBV Price Action: AbbVie stock is up 1.31% at $194.95 at publication Tuesday.

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