AbbVie has secured first-in-EU marketing approval for Rinvoq (upadacitinib) in severe alopecia areata after a positive CHMP opinion and subsequent European Commission decision in July 2026.
Rinvoq is the first JAK inhibitor approved in the EU for adult and adolescent patients 12 years and older with severe alopecia areata, offering a new systemic treatment option backed by Phase 3 UP-AA data showing scalp hair regrowth and in some cases complete regrowth (SALT = 0) at 24 weeks.
Rinvoq is already widely approved in the EU for inflammatory conditions including atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, axial spondylarthritis, giant cell arteritis, and has just gained a new indication in non‑segmental vitiligo, marking Rinvoq as the first systemic medication for NSV in the region.
Sources:
AbbVie Announces European Commission Approval of ...
Rinvoq - opinion on variation to marketing authorisation - EMA
AbbVie Secures EC Nod For RINVOQ In Severe Alopecia ...
AbbVie Gets Europe OK for Rinvoq in Vitiligo, Alopecia Areata
ABBV Gets CHMP Nod for Rinvoq in Two Different Autoimmune Diseases
AbbVie wins CHMP opinion for RINVOQ in alopecia
EU approves RINVOQ for severe alopecia areata, .. ...
AbbVie Announces European Commission Approval of ...
Rinvoq | European Medicines Agency (EMA)