AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Adults and Adolescents with Severe Alopecia Areata

AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved RINVOQ® (upadacitinib; 15 mg and 30 mg, once daily) for the treatment of adult and adolescent patients 12 years and older with severe alopecia areata (AA). "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." AA is an unpredictable autoimmune disease that causes a range of hair loss patterns, from sudden, round bald patches on the scalp to complete loss of all body hair, including scalp, face, eyebrows and eyelashes. Despite its immune-mediated nature, AA is often misunderstood as a cosmetic problem despite being associated with a wide-ranging impact on patients' lives contributing to the physical, psychological, social and economic burden. According to a population‐based study, patients with alopecia areata face up to 40% higher risk of being diagnosed with new-onset depression and anxiety compared to the general population, and this risk increases in women. Data Supporting the EC Approval The EC approval of RINVOQ is supported by previously reported data from the ongoing Phase 3 UP-AA clinical program (M23-716), which includes two replicate, randomized, placebo-controlled, double-blind studies evaluating the efficacy and safety of RINVOQ in adult and adolescent patients with severe AA. Both the 15 mg and 30 mg doses of RINVOQ in each study met the primary endpoint of SALT score ≤ 20 at week 24, with significantly more patients achieving ≥ 80% scalp hair coverage compared with placebo. Key secondary endpoints were also met for both doses in both studies, including complete scalp hair regrowth (SALT = 0) at week 24. The safety profile of both doses of RINVOQ in Period A was generally consistent with that observed in 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 is also approved in the European Union for the treatment of adults and adolescents with atopic dermatitis, and adults with radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and giant cell arteritis, and adults and adolescents with non-segmental vitiligo.