US biopharmaceutical company AbbVie (NYSE: ABBV) said on Monday it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending approval of upadacitinib for adults and adolescents with severe alopecia areata.

The opinion is based on the Phase 3 UP-AA clinical programme, in which both 15 mg and 30 mg doses met the primary endpoint of a Severity of Alopecia Tool score of 20 or less at week 24. Significantly more patients achieved at least 80% scalp hair coverage versus placebo, and key secondary endpoints were met, including complete scalp hair regrowth at week 24.

UP-AA comprises two replicate, randomised, placebo-controlled, double-blind studies spanning 52 weeks, with an optional extension into a third study. Across 248 sites worldwide, 1,399 participants aged 12 to 64 were randomised to receive upadacitinib or placebo.

Upadacitinib is already authorised in the European Union for several immune-mediated conditions, including atopic dermatitis, axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease and giant cell arteritis. It is also being studied in Phase 3 trials for hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo. Its safety and efficacy in alopecia areata remain under regulatory review in the US and EU.

A final decision from the European Commission is expected in the coming months.