AbbVie has won European Commission approval for Rinvoq (upadacitinib) to treat severe alopecia areata in adults and adolescents aged 12 and older, with once‑daily 15 mg and 30 mg doses authorised. Phase 3 UP‑AA trials involving 1,399 patients across 248 centres showed both doses met the primary endpoint of a SALT score ≤20 at week 24 and also achieved complete scalp hair regrowth (SALT = 0) by week 24. Safety findings were consistent with Rinvoq’s established profile; known risks include serious infections, malignancies, MACE and VTE. The drug remains under FDA review in the United States and will be available in the EU pending local reimbursement decisions.
EU Approves AbbVie’s Rinvoq for Severe Alopecia Areata in Patients 12+ — Phase 3 Trials Show Marked Hair Regrowth
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AbbVie (NYSE: ABBV) has received European Commission approval for Rinvoq (upadacitinib) to treat severe alopecia areata (AA) in adults and adolescents aged 12 years and older. The oral therapy will be available in once‑daily 15 mg and 30 mg doses for eligible patients across the EU, subject to local reimbursement and access arrangements.
Strong Phase 3 Evidence
The approval follows results from the Phase 3 UP‑AA clinical programme, which comprised two randomized, double‑blind, placebo‑controlled trials enrolling a combined 1,399 patients with severe AA across 248 study centres worldwide. Both the 15 mg and 30 mg doses met the primary endpoint: by week 24, treated patients achieved a Severity of Alopecia Tool (SALT) score ≤20, corresponding to at least 80% scalp hair coverage.
Key secondary outcomes were also met. Participants receiving Rinvoq demonstrated complete scalp hair regrowth (SALT = 0) by week 24 versus placebo, and AbbVie reports this is the first Janus kinase (JAK) inhibitor to show complete scalp hair regrowth compared with placebo at that treatment timepoint. Investigators also observed statistically meaningful improvements in eyebrow and eyelash regrowth among treated patients.
Safety and Use Considerations
AbbVie stated that safety findings from the UP‑AA programme were generally consistent with Rinvoq’s established safety profile across previously approved indications. Known risks associated with the medicine include serious infections, malignancies, major adverse cardiovascular events (MACE), venous thromboembolism (VTE) and other important safety considerations.
Rinvoq is contraindicated in patients with active tuberculosis, in those with severe hepatic impairment, and is not to be used during pregnancy. As with all systemic immunomodulatory therapies, treatment decisions should weigh potential benefits against known risks and be guided by clinical judgement.
Regulatory Status and Availability
The medicine is currently under evaluation by the U.S. Food and Drug Administration for the treatment of alopecia areata. Rinvoq already holds EU approvals for multiple immune‑mediated conditions, including atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and non‑segmental vitiligo.
Physicians and patients in the EU will now have an additional therapeutic option for severe AA, subject to national reimbursement decisions and local access. AbbVie and clinicians will continue monitoring long‑term safety and effectiveness as the drug is introduced for this new indication.
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