AbbVie ABBV announced that the European Commission has granted marketing approval to its blockbuster drug Rinvoq for treating giant cell arteritis (“GCA”), an autoimmune disease that causes inflammation of the medium to large arteries. GCA marks the eighth approved indication for Rinvoq.

Rinvoq (15 mg, once daily) is the first JAK inhibitor to be approved in the EU for the GCA indication and is also the first oral advanced therapy for treating the condition. The approval for GCA was based on data from the phase III SELECT-GCA study.

Data from the SELECT-GCA study showed that patients treated with Rinvoq can achieve sustained remission and reduce their cumulative steroid exposure, which are key treatment goals for GCA. In the study, 46% of the GCA patients treated with Rinvoq plus 26-week steroid taper regimen achieved the primary endpoint of sustained remission (absence of GCA signs and symptoms) from week 12 through week 52 versus 29% of patients administered placebo with a 52-week steroid taper regimen. The study also met its key secondary endpoints.

An application seeking approval of Rinvoq for GCA is also under review in the United States.

AbbVie stock has gained 6% so far this year against a decrease of 4.8% for the industry.

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Rinvoq’s Already Approved Indications

Rinvoq is already approved for seven immune-mediated inflammatory diseases in several countries, including the United States and the EU. These indications are radiographic axial spondylarthritis, nonradiographic axial spondylarthritis, psoriatic arthritis (“PsA”), rheumatoid arthritis (“RA”), ulcerative colitis (“UC”), Crohn's disease (“CD”) and atopic dermatitis. It is being studied in late-stage studies for some others like alopecia areata, systemic lupus erythematosus, hidradenitis suppurativa vitiligo and Takayasu arteritis.

Rinvoq is a Key Top-Line Driver for AbbVie

Rinvoq is a key top-line driver for AbbVie. The drug generated sales of almost $6 billion in 2024, which was up 50.4% year over year, owing to continuous label expansions of the drug to include new patient populations.

Rinvoq, along with AbbVie’s other inflammatory disease drug, Skyrizi, is performing extremely well, bolstered by approvals in new indications. 

Skyrizi and Rinvoq generated combined sales of $17.7 billion in 2024. The drugs are seeing strong performance across all their approved indications, especially in the popular inflammatory bowel disease space, which includes two conditions — UC and CD. Importantly, Skyrizi and Rinvoq have demonstrated compelling head-to-head data against several novel therapies in clinical studies, which has given them a competitive advantage.

AbbVie expects to record combined Skyrizi and Rinvoq sales of more than $31 billion in 2027. Strong immunology market growth, market share gains and momentum from new indications, such as the recent launch of Skyrizi in UC, as well as the potential for five new indications for Rinvoq over the next few years, including the newly approved GCA indication, are expected to drive these drugs’ growth.

Other Approved JAK Inhibitors

Janus kinase (JAK) inhibitors are small molecule drugs that target the JAK family of enzymes, interfering with the JAK-STAT signaling pathway, which is involved in the production of inflammatory cytokine. JAK inhibitors are approved to treat a variety of autoimmune and inflammatory diseases:

Some popular JAK inhibitor drugs available in the market are Pfizer’s PFE Xeljanz, Lilly LLY and Incyte’s INCY Olumiant (baricitinib) and Novartis/Incyte’s Jakafi.

Lilly/Incyte’s Olumiant (baricitinib) is approved for treating moderately to severely active RA and severe alopecia areata. Lilly and Incyte’s Olumiant generated sales of $957.4 million in 2024.

Pfizer’s Xeljanz is a much older drug and is approved to treat RA, PsA, UC and ankylosing spondylitis. Pfizer’s Xeljanz generated sales of $1.17 billion in 2024.

ABBV’s Zacks Rank

AbbVie has a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

AbbVie Inc. Price and Consensus

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