CLAIM #2709 · AbbVie Inc (ABBV) · 2025Q4 earnings call · Feb 4, 2026 · due Dec 31, 2026
“Regulatory applications for RINVOQ in alopecia areata are under review in Europe and Japan, with approval decisions expected later this year.”
Roopal Thakkar · Chief Scientific Officer
How to check this claim
Look at: Regulatory approval decisions for RINVOQ in alopecia areata in Europe (EMA) and Japan (PMDA/MHLW)
It came true if: Both Europe and Japan issue an approval decision (positive or negative) for RINVOQ in alopecia areata by 2026-12-31
Where: Company press releases / EMA and Japan regulatory agency disclosures / AbbVie 10-K or quarterly pipeline updates
In context
“also a clear priority. We look forward to commercializing Trinibot e, a fast-acting short-duration toxin, which is expected to be approved in the US later this year. So overall, I'm extremely pleased with the execution across our commercial portfolio, which is demonstrating very, very strong momentum as we head into 2026. And with that, I will turn the call over to Roopal for comments on our R&D highlights. Roopal? Thank you, Jeffrey. Roopal Thakkar: I'll start with immunology, where we are on track for numerous important data readouts across all stages of our pipeline this year, as well as several regulatory submissions and approvals. Regulatory applications for RINVOQ in nonsegmental vitiligo were recently submitted, with an approval decision in the US anticipated in the fourth quarter. Regulatory applications for RINVOQ in alopecia areata are under review in Europe and Japan, with approval decisions expected later this year. Our US submission is planned for the second quarter. Over the course of 2026, results from several late-stage programs are anticipated, including phase three data from studies for both RINVOQ and lutekizumab in hidradenitis suppurativa, and a study evaluating subcutaneous induction with SKYRIZI in Crohn's disease. We continue to make substantial progress with our early and mid-stage programs as well, where we have an exciting pipeline of next-generation therapies that have the potential to drive higher efficacy relative to standard of care. This year, we'll see data from our Crohn's disease platform study, evaluating SKYRIZI in combination with our novel anti-alpha four beta seven antibody ABBV 3A2 and our anti-IO one alpha beta bispecific, lutekizumab. Our extended half-life TL1A antibod”
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SEC filings for ABBV ↗ · Claim quote is verbatim from the 2025Q4 earnings call.