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AbbVie’s Rinvoq Wins 11th EU Approval in Pediatric Arthritis

AbbVie’s Rinvoq has picked up its 11th European Union approval, this time for pediatric arthritis, extending the drug’s expansion as AbbVie leans on it to replace lost Humira sales.

AbbVie (NYSE: ABBV), the pharmaceutical group, said the European Commission has approved its drug Rinvoq for active polyarticular juvenile idiopathic arthritis, a form of childhood arthritis, in patients aged two and older. The shares closed at $265.32 on Tuesday, up 0.33% from the previous close of $264.48.

That close sits near the top of ABBV’s 52-week range of $189.40 to $267.47, though the approval itself produced no discernible price reaction, consistent with a label expansion of modest standalone financial weight rather than a stock-moving event.

The approval covers Rinvoq’s 15mg tablet and a new weight-based oral solution, for patients who have had an inadequate response to, or are intolerant of, DMARDs, a class of disease-modifying drugs. It can be used alone or with methotrexate. Regulators based the decision on the open-label SELECT-YOUTH study together with adult rheumatoid arthritis data; at week 48, 79.5% of patients achieved an ACR Pediatric 70 response, a standard measure of improvement in juvenile arthritis symptoms, and 43.4% reached clinical remission.

Rinvoq has become AbbVie’s key growth driver since Humira, once the group’s top-selling drug, lost US patent protection. Sales of Rinvoq rose 22.2% year-on-year to $4.64 billion in the first half of 2026, and AbbVie is guiding to roughly $10.2 billion for the full year. Juvenile idiopathic arthritis affects an estimated 126,000 children in Europe, a modest addressable population next to Rinvoq’s existing indications, which is why this approval adds to the growth story without acting as a standalone catalyst.

Roopal Thakkar, AbbVie’s Executive Vice President of Research and Development and Chief Scientific Officer, said the approval matters for patients as much as for the label count.

The European Commission’s approval of RINVOQ for pJIA expands the treatment options available to pediatric patients and their families, offering the potential for remission, improvements in pain and physical function. RINVOQ’s new indication continues to build on our differentiated immunology portfolio with breadth and depth across therapeutic areas and patient populations.

Roopal Thakkar, AbbVie

The approval is Rinvoq’s 11th in the European Union, another sign of the immunology drug’s steady expansion across immune-mediated diseases as AbbVie builds its case that the Rinvoq-and-Skyrizi combination can carry the group’s growth beyond Humira.

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