US biopharmaceutical company AbbVie (NYSE: ABBV) said on Wednesday it has received European Commission approval for RINVOQ (upadacitinib) to treat adults and adolescents aged 12 and over with severe alopecia areata when taken once daily in either a 15mg dose or a 30mg dose.

The decision is based on pivotal data from the Phase 3 UP-AA clinical program showing statistically significant scalp hair regrowth, with both doses meeting the primary endpoint of Severity of Alopecia Tool (SALT) score ≤ 20 at week 24 and delivering improvements in eyebrows and eyelashes. RINVOQ is also the first JAK inhibitor to achieve complete scalp hair regrowth (SALT = 0) versus placebo at week 24.

Alopecia areata is an autoimmune condition causing patchy or complete hair loss across the body and is associated with physical, psychological, social and economic burden. Population-based research indicates patients face up to 40% higher risk of new-onset depression and anxiety, with elevated risk in women.

The UP-AA programme comprises two replicate, randomised, placebo-controlled, double-blind Phase 3 studies involving 1,399 participants aged 12 to 64 across 248 sites worldwide. Periods A and B span 52 weeks, with an optional extension study of up to 108 weeks.

Safety outcomes for both doses in Period A were generally consistent with those seen in approved indications. RINVOQ already holds EU approval for multiple immune-mediated conditions, including atopic dermatitis, axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, giant cell arteritis and non-segmental vitiligo.

Upadacitinib is also being studied in Phase 3 trials for hidradenitis suppurativa, Takayasu arteritis and systemic lupus erythematosus, and remains under regulatory review for alopecia areata by the US FDA.