Dupixent indication expanded to bullous pemphigoid and CSU

Expands reach into rare and difficult-to-treat skin diseases driven by Type 2 inflammation

Dupixent pre-filled pen

Sanofi announced that its Type 2 inflammation-targeting therapy ‘Dupixent (dupilumab)’ has been approved for two new indications -- bullous pemphigoid (BP) and chronic spontaneous urticaria (CSU).

With this approval, Dupixent has become the first and only targeted therapy approved in Korea for the treatment of BP. It also provides an additional treatment option for patients with CSU whose symptoms are not adequately controlled with H1-antihistamine therapy.

With the approval, Dupixent pre-filled syringe and pre-filled pen 300 mg may be used for the treatment of bullous pemphigoid in adults aged 18 years and older, and Dupixent pre-filled syringe and pre-filled pen 200 mg and 300 mg formulations may be used for the treatment of CSU in adults aged 18 years and older and adolescents aged 12–17 years whose symptoms are inadequately controlled with H1-antihistamines.

Dupixent demonstrated clinical efficacy in adults with moderate-to-severe bullous pemphigoid in the ADEPT Phase II/III clinical trial, which served as the basis for the approval.

Patients received Dupixent 300 mg in combination with standard systemic corticosteroid therapy, followed by gradual tapering according to disease status. At Week 36, the proportion of patients who achieved sustained disease control without oral corticosteroids (OCS) was higher in the Dupixent group than in the placebo group.

The recently published 2025 Canadian Dermatology Association (CDA) Guidelines included Dupixent as a first-line treatment option for extensive bullous pemphigoid. In addition, the 2022 S2K International Expert Consensus Guidelines issued by the European Academy of Dermatology and Venereology (EADV) recommend Dupixent as a biologic treatment option for treatment-resistant bullous pemphigoid.

Dupixent’s indication expansion to chronic spontaneous urticaria was based on results from the Phase III CUPID trial, which enrolled biologic-naïve patients aged 6 years and older whose symptoms persisted despite H1-antihistamine therapy.

The primary endpoint was the change from baseline in the Weekly Itch Severity Score (ISS7) at Week 24. Key secondary endpoints included changes in the Urticaria Activity Score over 7 Days (UAS7), achievement of symptom control (UAS7 ≤ 6), and complete remission (UAS7 = 0). In the study, patients treated with Dupixent experienced a statistically significant reduction in itch severity (ISS7) compared with placebo, and the reduction in UAS7 from baseline was 66% in the Dupixent group and 48% in the placebo group, respectively.

Previously, first-line treatment for chronic spontaneous urticaria consisted of second-generation H1-antihistamines, which could be increased to as much as four times the standard dose. However, a substantial unmet need persists because nearly half of patients fail to achieve adequate symptom control with H1-antihistamines alone. To address this, the 2026 international guideline update formally included Dupixent alongside omalizumab as a targeted second-line therapy for H1-antihistamine-refractory chronic spontaneous urticaria.

Kyung-eun Bae, General Manager of Sanofi Korea, said, “Through these two indication expansions, we hope that patients suffering from poor quality of life associated with bullous pemphigoid and chronic spontaneous urticaria will receive the best possible treatments, improve their quality of life, and receive a higher standard of care. We will continue our efforts to improve the treatment environment for these patients.”