AbbVie Inc. (NYSE:ABBV) said on September 22 that the European Commission has approved Rinvoq for children aged two and older with active polyarticular juvenile idiopathic arthritis. The approval covers patients who did not respond to, or could not tolerate, standard disease-modifying drugs. It is the eleventh indication Rinvoq holds in Europe.
The Commission also cleared a new oral solution dosed by weight, alongside the existing tablet. A weight-dosed liquid is what makes the drug usable in a two-year-old at all. About 126,000 children in Europe have juvenile idiopathic arthritis, which AbbVie describes as the most common rheumatic disease of childhood. The polyarticular form is one subtype of it.
Every New Indication Extends the Life of AbbVie’s Humira Replacement:
Rinvoq and Skyrizi are the two drugs AbbVie is counting on to replace Humira, whose sales have fallen sharply since biosimilars arrived. The way Rinvoq grows is by collecting indications. Each approval opens another patient group without the cost of inventing a new medicine.
The count is the story, because a child who starts Rinvoq at two has far more years of treatment ahead than an adult starting at fifty. No adult indication buys that kind of duration. Rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, and atopic dermatitis are the large ones. Paediatric arthritis adds a smaller group but a much longer one.
The data was strong enough that regulators approved it down to age two. In the single-arm SELECT-YOUTH study, 79.5% of children had reached a 70% improvement in disease activity by 48 weeks. That study was small and had no comparator group, which is why regulators also leaned on AbbVie’s adult data. Durable results give paediatric rheumatologists a reason to prescribe, though the class warnings below will shape how quickly they do.
The Patient Group is Small and the Competition is Not:
Nothing about this approval changes AbbVie’s revenue arithmetic this year. The whole of European juvenile arthritis is small next to Rinvoq’s adult indications, and only a subset has the polyarticular form. Revenue per patient in paediatrics is lower than in adult rheumatology.
Rinvoq also belongs to a drug class regulators have watched closely. JAK inhibitors carry warnings on serious infections, blood clots and cardiovascular events. Those came from a safety study of a different drug in the class, in patients aged 50 and over who already had heart risk factors. Prescribing one to a two-year-old means parents and paediatricians read those warnings first. The wording is also not fixed, and a regulator reopening it would hit every Rinvoq indication at once.
The core problem is unchanged, which is that Rinvoq and Skyrizi together must outrun Humira’s decline. Skyrizi is doing the heavy lifting, and Rinvoq is doing the widening. Skyrizi brought in $5.5 billion last quarter against Rinvoq’s $2.5 billion. An eleventh indication adds volume, not weight. Skyrizi is still the drug carrying AbbVie’s post-Humira transition.
Conclusion:
AbbVie has added another indication to one of the two drugs replacing Humira, with strong trial results and a formulation designed for young children. However, the patient group is small, revenue per patient is lower in paediatrics, and the safety warnings attached to JAK inhibitors will slow how quickly doctors reach for it. The number to watch is Rinvoq’s growth rate when AbbVie reports in late October. If indications keep stacking while that rate fades, the strategy is a treadmill rather than a moat.
Market Sentiment:
AbbVie Inc. was held by 88 hedge funds with a combined stake value of about $8.6 billion at the end of Q2 2026 in the Insider Monkey database. This is up from 87 hedge fund holders with a cumulative investment value of around $4.3 billion in the previous quarter.
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This article is originally published at Insider Monkey.
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