Press Release: Dupixent approved in the US as the only targeted medicine to treat patients with bullous pemphigoid

Core Viewpoint - Dupixent (dupilumab) has been approved by the US FDA as the only targeted treatment for adult patients with bullous pemphigoid (BP), a chronic skin disease primarily affecting the elderly [1][4][5]. Group 1: Disease Overview - Bullous pemphigoid primarily affects elderly patients and is characterized by intense itching, painful blisters, and skin lesions, leading to increased infection risk and impaired daily functioning [2][3]. - Current treatment options for BP are limited and often involve immunosuppressive therapies that can exacerbate the disease burden [2][3]. Group 2: Dupixent Approval and Efficacy - The FDA approval of Dupixent is based on the pivotal ADEPT phase 2/3 study, which demonstrated significant improvements in sustained disease remission and itch reduction compared to placebo [4][6][8]. - In the study, 18.3% of patients on Dupixent achieved sustained disease remission at 36 weeks compared to 6.1% for placebo, with a 12.2% difference [6][9]. - Additionally, 38.3% of patients on Dupixent experienced clinically meaningful itch reduction compared to 10.5% for placebo [6]. Group 3: Treatment Protocol and Safety - Dupixent is administered as a subcutaneous injection at a dosage of 300 mg every two weeks after an initial loading dose, in conjunction with a tapering course of oral corticosteroids [10][11]. - The most common adverse events (≥2%) observed in patients treated with Dupixent included arthralgia, conjunctivitis, and herpes viral infections [4][6]. Group 4: Broader Implications and Future Directions - Dupixent is now approved for treating eight distinct diseases associated with type 2 inflammation, indicating its potential to transform treatment paradigms for various conditions [5][7]. - The approval reinforces Dupixent's safety profile across a broad age range, with ongoing regulatory applications in other regions, including the EU, Japan, and China [7][13].