AbbVie announced that the European Commission has approved Rinvoq (upadacitinib) for the treatment of severe alopecia areata in adults and adolescents 12 years and older — adding a tenth indication for the JAK inhibitor in the European Union.
Alopecia areata is an unpredictable autoimmune disease that can cause hair loss ranging from patchy bald spots to complete loss of scalp, eyebrow, eyelash and other body hair. Despite its immune-mediated nature, the condition is frequently dismissed as a cosmetic issue, though it carries substantial physical, psychological, social and economic consequences. Research has found that patients with alopecia areata face up to a 40% higher risk of new-onset depression and anxiety compared to the general population, with women at even greater risk.
The EC approval is based on data from the Phase 3 UP-AA clinical program, two replicate randomized, placebo-controlled, double-blind studies enrolling 1,399 participants with severe alopecia areata across 248 sites worldwide. Both the 15 mg and 30 mg once-daily doses met the primary endpoint — a Severity of Alopecia Tool (SALT) score of 20 or lower at week 24, signifying at least 80% scalp hair coverage. Key secondary endpoints were also met in both studies, including complete scalp hair regrowth (SALT score of 0) at week 24, making Rinvoq the first JAK inhibitor to achieve that benchmark versus placebo. Improvements in eyebrows and eyelashes were also demonstrated. The safety profile was consistent with Rinvoq's established profile across other approved indications.
"This approval provides another option for patients who continue to navigate physical and mental burden associated with severe alopecia areata, often overlooked due to stigma," said Roopal Thakkar, AbbVie's chief scientific officer.
Upadacitinib for alopecia areata remains under regulatory review by the U.S. FDA.
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