AbbVie advances RINVOQ EU approval

• AbbVie (NYSE:ABBV) received a positive CHMP opinion recommending EU approval of RINVOQ for severe alopecia areata.
• The recommendation is based on Phase 3 UP-AA data showing scalp hair regrowth outcomes at week 24.
• A final European Commission decision is expected in the coming months.

AbbVie (NYSE:ABBV) said the CHMP has issued a positive opinion recommending approval of upadacitinib (RINVOQ) 15 mg and 30 mg once daily for adults and adolescents with severe alopecia areata in the EU.

The recommendation follows Phase 3 UP-AA trial results that showed patients achieving SALT ≤ 20 and some reaching complete scalp regrowth, defined as SALT = 0, at week 24.

The CHMP opinion is not final approval and will now be reviewed by the European Commission, which is expected to make a decision in the coming months.

The safety profile reported in the Phase 3 program was generally consistent with already approved uses of RINVOQ in other conditions.

RINVOQ is part of AbbVie’s immunology portfolio, which includes treatments targeting immune-mediated inflammatory diseases across dermatology and rheumatology.

AbbVie continues to expand label opportunities for existing therapies while advancing additional indications through late-stage clinical development programs.