Healthcare
AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults and Adolescents with Severe Alopecia Areata
AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) for the treatment of adult and adolescent patients with severe alopecia areata (AA). The final European Commission decision is expected in the coming months.
About this update from Abbvie Inc.
NORTH CHICAGO, Ill., June 29, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) for the treatment of adult and adolescent patients with severe alopecia areata (AA). The final European Commission decision is expected in the coming months. "Alopecia areata is an unpredictable autoimmune disease with underrecognized patient burden," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "The CHMP's positive opinion for upadacitinib is a step closer to bringing a new treatment option to patients living with severe alopecia areata." The CHMP positive opinion is supported by data from the ongoing Phase 3 UP-AA clinical program (M23-716), which includes two replicate, randomized, placebo-controlled, double-blind studies evaluating the efficacy and safety of upadacitinib in adult and adolescent patients with severe alopecia areata. Both the 15 mg and 30 mg doses of upadacitinib in each study met the primary endpoint of SALT score ≤ 20 at week 24, with significantly more patients achieving ≥ 80% scalp hair coverage compared with placebo. Key secondary endpoints were also met for both doses in both studies, including complete scalp hair regrowth (SALT = 0) at week 24. The safety profile of both doses of upadacitinib in Period A was generally consistent with that observed in approved indications.1,2 Upadacitinib is approved in the European Union (EU) for the treatment of adults and adolescents with atopic dermatitis, and adults with radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and giant cell arteritis. Use of upadacitinib in AA is not currently approved in the EU. About Alopecia AreataAlopecia areata (AA) is an unpredictable autoimmune disease causing a range of hair loss patterns, from sudden, round bald patches on the scalp to complete loss of all body hair, including scalp, face, eyebrows and eyelashes.3,4 Despite its immune-mediated nature, AA is often considered a cosmetic problem, which can lead to stigma and have an impact on patients' lives.5,6