AbbVie (NYSE:ABBV) has received European Commission approval for Rinvoq (upadacitinib) as a treatment for severe alopecia areata (AA) in adults and adolescents aged 12 years and older, expanding the medicine’s approved uses across the European Union.
The therapy will be available in 15 mg and 30 mg once-daily doses for eligible patients.
Phase 3 Studies Demonstrated Strong Hair Regrowth Results
The approval is supported by findings from the Phase 3 UP-AA clinical development programme, which included two randomized, double-blind, placebo-controlled trials involving 1,399 patients with severe alopecia areata at 248 study centres worldwide.
Both Rinvoq dose levels successfully achieved the primary endpoint, with patients reaching a Severity of Alopecia Tool (SALT) score of 20 or lower after 24 weeks of treatment, indicating at least 80% scalp hair coverage.
The studies also met key secondary endpoints. Participants receiving Rinvoq achieved complete scalp hair regrowth, defined as a SALT score of zero, by week 24. According to AbbVie, Rinvoq is the first JAK inhibitor to demonstrate complete scalp hair regrowth compared with placebo at that point in treatment.
Researchers also observed improvements in eyebrow and eyelash regrowth among treated patients.
Safety Profile Remains Consistent
AbbVie said the safety findings from the clinical programme were generally consistent with Rinvoq’s established safety profile across its previously approved indications.
Known risks associated with the medicine include serious infections, malignancies, major adverse cardiovascular events, venous thromboembolism and other important safety considerations.
Rinvoq is contraindicated in patients with active tuberculosis, severe hepatic impairment and during pregnancy.
U.S. Regulatory Review Continues
The medicine is also being evaluated by the U.S. Food and Drug Administration for the treatment of alopecia areata.
Rinvoq is already approved in the European Union for several immune-mediated diseases, including atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and non-segmental vitiligo, among other indications.
AbbVie stock price
