EU Approves AbbVie's Rinvoq for Severe Alopecia Areata and Vitiligo

The European Commission approved AbbVie's ABBV Rinvoq (upadacitinib) on July 29, 2026 for two new indications: severe alopecia areata and non-segmental vitiligo in adults and adolescents 12 and older. The vitiligo nod covers adult and adolescent candidates for systemic therapy.

Neither is first-in-class. Eli Lilly's LLY Olumiant (baricitinib) was the EU's first JAK inhibitor approved for severe alopecia areata in 2022, and Pfizer's Litfulo followed in 2023, making Rinvoq the third systemic option. In vitiligo, Incyte's INCY Opzelura cream has held EU approval for facial non-segmental vitiligo since 2023, but as a topical, leaving Rinvoq the first oral systemic medicine approved there.

Both approvals rest on phase 3 data: UP-AA showed significant scalp hair regrowth by week 24, and Viti-Up showed significant body and facial repigmentation by week 48 versus placebo. Rinvoq posted $8.3 billion in global net revenue in 2025, up from $6.0 billion in 2024, expanding across rheumatology, gastroenterology and dermatology.

US regulators have not yet acted: AbbVie filed for FDA approval in alopecia areata in April 2026 and vitiligo in February 2026, both still under review. Generic settlements already push US exclusivity to at least 2037, so the watch points are the FDA timeline and EU uptake, not a patent cliff.

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