AbbVie Secures Rare Disease Drug Designation for Upadacitinib in Hidradenitis Suppurativa

AbbVie Achieves Rare Disease Drug Designation for Upadacitinib

AbbVie, headquartered in Minato-ku, Tokyo, has recently announced that it has secured a rare disease drug designation from the Ministry of Health, Labour and Welfare for Upadacitinib, specifically for treating Hidradenitis Suppurativa (HS) in adults and children aged 12 and above. This designation, granted as of September 25, 2026, aims to facilitate the development of new treatment options for diseases with a small patient base and high medical necessity.

Hidradenitis Suppurativa is characterized by painful recurrent skin eruptions and scarring due to chronic inflammation. The disease typically manifests in areas such as the armpits, groin, beneath the breasts, and around the genital and buttock regions, and it commonly presents after puberty. This condition not only causes significant physical discomfort but also severely impacts the quality of life of patients. In Japan, there are approximately 3,000 reported patients aged between 15 and 64, indicating a prevalence rate of about 0.0039%.

Currently, treatment options for moderate to severe cases of HS in Japan are limited. Despite the existence of some approved therapies, there remains a notable patient population that does not achieve satisfactory results from these treatments. Moreover, there are no approved medications specifically for children over 12 years old with HS, highlighting the urgent need for new therapeutic options to meet the substantial unmet medical needs of these patients.

In response to this situation, AbbVie is conducting an international Phase 3 clinical trial (M23-698 study) aimed at evaluating Upadacitinib in adult and pediatric HS patients aged 12 and older, particularly those who have not responded adequately to existing biological therapies or have encountered tolerability issues.

About Upadacitinib

Developed by AbbVie, Upadacitinib is a low-molecular-weight selective Janus kinase (JAK) inhibitor that is being explored as a treatment for various immune-mediated conditions. The drug shows functional selectivity, preferentially inhibiting signaling through JAK1 and JAK1/3 compared to JAK2, thereby delivering precise therapeutic effects.

AbbVie’s Commitment

AbbVie’s mission is to develop innovative pharmaceuticals that address pressing health issues and to confront future medical challenges with groundbreaking solutions. The company is focused on several key areas, including immune disorders, neurosciences, oncology, and aesthetic medical products and services through its Allergan Aesthetics portfolio. For more information on AbbVie, you can visit www.abbvie.com and stay connected through LinkedIn, Facebook, Instagram, Twitter, and YouTube.

In Japan, AbbVie is dedicated to developing and providing products mainly in the areas of immune disorders, liver diseases, mental health, cancer, eye care, and aesthetics. For more details, visit www.abbvie.co.jp and follow their updates on Facebook and YouTube.

References

1. Zouboulis CC, Desai N, Emtestam L, et al. European S1 guideline for the treatment of hidradenitis suppurativa/acne inversa. J Eur Acad Dermatol Venereol. 2015;29:619-644.
2. Hayama K, Fujita H, et al. Overall Impairment of Quality of Life in Japanese Patients with Hidradenitis Suppurativa: Comparison with National Standard. Acta Derm Venereol. 2022.
3. Terui Masashi, Torii Hidetoshi, Kurokawa Ichiro. Survey Research on Hidradenitis Suppurativa. Clinical Dermatology. 2018;60:353-360.
4. Health Labour Science Research Grant, Research Project on Intractable Diseases, “Comprehensive Study of Rare Intractable Skin Diseases Associated with Genetic Factors” Final Report (2023). Available at: https://mhlw-grants.niph.go.jp/system/files/report_pdf/202310065A-soukatu.pdf
5. RINVOQ Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; May 2021. Available at: [https://www.ema.europa.eu/en/documents/productinformation/rinvoqepar-product-information_en.pdf