EC grants approval for AbbVie’s RINVOQ in adults and adolescents with severe alopecia areata

The European Commission has recently granted approval for RINVOQ at 15 mg and 30 mg once daily for the treatment of adults and adolescents aged 12 and above with severe alopecia areata.

“The European Commission’s approval of RINVOQ provides a new treatment option for the severe alopecia areata community in the EU with demonstrated scalp regrowth, including complete scalp hair regrowth for some, that can support management of the disease,” said Roopal Thakkar, M.D., Executive Vice President, Research and Development, Chief Scientific Officer, AbbVie. “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.”

Alopecia areata is an unpredictable autoimmune condition that produces a wide spectrum of hair loss, ranging from sudden circular bald patches on the scalp to complete loss of hair across the body, including the face, eyebrows, and eyelashes. Despite its immune-driven origin, the condition is frequently dismissed as a cosmetic issue, yet it carries a substantial burden spanning the physical, psychological, social, and economic dimensions of patients’ lives. Research suggests that people with alopecia areata face up to a 40% greater likelihood of developing depression or anxiety compared to the broader population, with women facing an even higher risk.

The European Commission’s decision is grounded in previously reported data from the ongoing Phase 3 UP-AA clinical programme, which comprises two replicate randomised, placebo-controlled, double-blind studies evaluating the efficacy and safety of RINVOQ in adults and adolescents with severe alopecia areata. Both the 15 mg and 30 mg doses satisfied the primary endpoint of a SALT score at or below 20 at week 24 in each study, with a significantly greater proportion of patients achieving 80% or more scalp hair coverage compared to those on placebo. Key secondary endpoints were also met at both doses across both studies, including complete scalp hair regrowth at week 24. The safety profile for both doses was broadly in line with what has been established across RINVOQ’s approved indications.

“Alopecia areata is a complex condition to treat often due to its unpredictable disease course and prognosis,” said Thierry Passeron, M.D., Ph.D., Professor and Chair, Department of Dermatology, Université Côte d’Azur. “The UP-AA results based on stringent endpoints demonstrated clinically meaningful scalp hair regrowth and improvements in eyebrows and eyelashes in 24 weeks, supporting RINVOQ as an important new treatment option for severe alopecia areata patients in Europe.”

RINVOQ holds further EU approval for adults and adolescents with atopic dermatitis and non-segmental vitiligo, as well as for adults across a range of additional conditions including radiographic and non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn’s disease, and giant cell arteritis.

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AbbVie's RINVOQ, European Commission, severe alopecia areata