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艾伯维宣布RINVOQ® (upadacitinib) 两项新适应症获欧盟批准

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  • RINVOQ® is now approved in the European Union for the treatment of adult and adolescent patients with severe alopecia areata (AA)

  • Approval was based on the pivotal Phase 3 UP-AA clinical program, which showed that RINVOQ achieved statistically significant scalp hair regrowth (Severity of Alopecia Tool (SALT) score ≤ 20) and improvements in eyebrows and eyelashes at week 241

  • RINVOQ is the first JAK inhibitor to achieve complete scalp hair regrowth (SALT = 0) versus placebo at week 24

 

NORTH CHICAGO, Ill., July 29, 2026 /PRNewswire/ -- 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).1

 

"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.2,3 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.4,5 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.6,7

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.1

 

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.1

 

"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.1

 

About UP-AA Clinical Trials 


UP-AA M23-716 was conducted as a single protocol that includes two replicate pivotal studies (Study 1 and Study 2) with randomization, investigative sites, data collection, analysis and reporting independent for each study. The Phase 3 randomized, placebo-controlled, double-blind studies evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with severe alopecia areata. In Study 1 and Study 2 Period A, participants are randomized to one of three groups to receive upadacitinib 15 mg, upadacitinib 30 mg or placebo for 24 weeks. In Study 1 and Study 2 Period B, participants originally randomized to upadacitinib dose groups in Period A will continue their same treatment in Period B for 28 weeks. Participants originally randomized to placebo in Period A will either remain on placebo in Period B, or be randomized in one of two groups, based on their SALT score at week 24. In total, Study 1 and Study 2 Periods A and B span 52 weeks. Participants who complete Study 1 or Study 2 can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. The two trials randomized 1,399 participants with severe AA ages 12 to 64 across 248 sites worldwide. More information on this trial can be found at www.clinicaltrials.gov (NCT06012240).

 

About RINVOQ® (upadacitinib)


Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.1,8 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK 1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.1

 

Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for hidradenitis suppurativa, Takayasu arteritis and systemic lupus erythematosus. The use of upadacitinib in alopecia areata is also under regulatory review by the U.S. FDA.

 

About AbbVie in Immunology


AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For more than 20 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of actions and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease.

 

Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 19 immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. 

 

About AbbVie


AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio.

 

References

  1. RINVOQ. Package insert. North Chicago, IL: AbbVie Inc.; 2026.

  2. Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: part I. Clinical picture, histopathology, and pathogenesis. J Am Acad Dermatol. 2010;62(2):177-188, quiz 189-190. doi:10.1016/j.jaad.2009.10.032

  3. Pratt CH, King LE, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017;3(1):17011. doi:10.1038/nrdp.2017.11

  4. Davey L, Clarke V, Jenkinson E. Living with alopecia areata: an online qualitative survey study. Br J Dermatol. 2019;180(6):1377-1389. doi:10.1111/bjd.17463

  5. Bain KA, McDonald E, Moffat F, et al. Alopecia areata is characterized by dysregulation in systemic type 17 and type 2 cytokines, which may contribute to disease-associated psychological morbidity. Br J Dermatol. 2020;182(1):130-137. doi:10.1111/bjd.18008

  6. Macbeth AE, Holmes S, Harries M, et al. The associated burden of mental health conditions in alopecia areata: a population-based study in UK primary care. Br J Dermatol. 2022;187(1):73-81. doi:10.1111/bjd.21055

  7. Marahatta S, Agrawal S, Adhikari BR. Psychological impact of alopecia areata. Dermatol Res Pract. 2020;2020:8879343. doi:10.1155/2020/8879343

  8. Pipeline. AbbVie. 2026. Accessed July 27, 2026. https://www.abbvie.com/science/pipeline.html

文章关键词： 艾伯维RINVOQ® (upadacitinib)欧盟
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