AbbVie Gets EU Nod for RINVOQ in Alopecia Areata and Vitiligo

AbbVie (NYSE:ABBV) announced that it has received positive opinions from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the use of RINVOQ (upadacitinib) in the treatment of severe alopecia areata and non-segmental vitiligo.

The Product

RINVOQ is an oral selective JAK1 inhibitor already approved in Europe for several dermatological and immunological indications. The new indications target areas with high unmet medical need in dermatology and immunology. If approved, RINVOQ would be the first systemic therapy for non-segmental vitiligo in Europe.

Pricing and Availability

AbbVie has not yet disclosed pricing or expected availability. CHMP opinions are typically followed by formal European Commission approval within two months.

Competition

In alopecia areata, RINVOQ faces competition from Eli Lilly's Olumiant (baricitinib), already approved in Europe for the same indication. In non-segmental vitiligo, no systemic therapy is currently approved in Europe, giving RINVOQ a first-mover advantage.

Potential Impact on the Company

RINVOQ is a core asset in AbbVie's portfolio alongside Humira and Skyrizi. Expanding indications boosts RINVOQ revenue and partially offsets Humira's biosimilar erosion. However, competition in alopecia remains.