Dupixent (dupilumab) has been approved by the FDA for the treatment of adult patients with bullous pemphigoid (BP), a chronic autoimmune skin disorder, Sanofi announced Friday. Dupixent is now approved to treat eight diseases with underlying type 2 inflammation and is the only targeted medicine for the treatment of BP.
3D structure of dupilumab’s antigen-binding fragment complexed with human interleukin-4 receptor alpha (IL-4Rα). PDB ID: 6WGL, Lieu et al., licensed under Creative Commons 4.0.
FDA approval based on clinical study results: disease remission and itch reduction
This new FDA approval is based on results from the ADEPT phase 2/3 study, which evaluated Dupixent compared to placebo in adults with moderate to severe BP for a 52-week treatment period. The study had 106 participants with moderate to severe BP. Patients were randomly assigned to receive either Dupixent 300 mg or placebo, in addition to standard-of-care oral corticosteroids (OCS), every two weeks after an initial loading dose. OCS was tapered off after patients experienced two weeks of sustained control of the disease activity. Tapering was initiated four to six weeks after randomization and was continued if disease control was maintained. After tapering, patients were treated only with Dupixent or placebo for at least 20 weeks.
Results of the study showed that 18.3% of patients experienced sustained disease remission on Dupixent compared to 6.1% for the placebo after 36 weeks. Additionally, 38.3% of patients achieved clinically meaningful itch reduction on Dupixent compared to 10.5% on placebo after 36 weeks.
Dupixent is a Sanofi-Regeneron growth driver
The drug, co-developed by Sanofi and Regeneron, is following a similar course to AbbVie’s Humira (adalimumab), a fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody, in terms of its growing roster of indications. Dupixent is now approved as a treatment for eczema (atopic dermatitis), asthma, chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria and BP.
In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin and lichen simplex chronicus.
The drug generated $14.15 billion in sales between Regeneron and Sanofi in 2024, representing a 22% year-over-year jump.
Leonard Schleifer, Co-Chairman of the Board, President and Chief Executive Officer of Regeneron reported that first quarter 2025 net product sales of Dupixent grew 20% globally on a constant currency basis compared to the first quarter of 2024, “reflecting strong growth across all approved indications in all age groups and all geographic regions.”
“Dupixent now also leads total prescription share across all approved indications,” said Paul Hudson, CEO of Sanofi.
The need for a new BP treatment
BP is a rare skin condition that causes large, fluid-filled blisters. The main treatment for BP is corticosteroid medicine, which is applied to the affected area. Other treatments include oral steroids, antibiotics and medicines that target the immune system. However, approximately 27,000 adults in the US have BP that is uncontrolled by systemic corticosteroids. According to Sanofi, “Available treatment options are limited and can add to overall disease burden by suppressing a patient’s immune system.” Dupixent fills this gap in available BP treatments.
BP primarily affects elderly patients. It is characterized by an intense itch, painful blisters and lesions. It can cause patients to be more prone to infection and impact their daily functioning. BP occurs when the immune system attacks a layer of tissue in the skin. It can be caused by certain medications.
Filed Under: clinical trials, Dermatology, Immunology
