Sanofi/Regeneron's Dupilumab Gains FDA Approval for Adult Bullous Pemphigoid, Becoming First Targeted Therapy in the U.S.

On June 20 local time, Regeneron and Sanofi jointly announced that the U.S. FDA had approved the supplemental Biologics License Application for dupilumab.For the treatment of adult bullous pemphigoid（BP）This approval makes dupilumab the first and only targeted treatment for BP in the United States.

BP is a chronic recurrent autoimmune skin disease characterized by severe itching, skin blisters, redness, swelling, and painful lesions. In severe cases, blisters and rashes can spread throughout the body, leading to skin bleeding, crusting, significantly increasing the risk of infection, and seriously affecting the patient's daily living ability. In the United States, approximately 27,000 adult patients cannot control their condition with traditional systemic glucocorticoids.（OCS）Control, there is an urgent need for safer and more effective treatment options.

Dupilumab, a fully human monoclonal antibody jointly developed by Sanofi and Regeneron, precisely modulates inflammatory responses by inhibiting the signaling pathways of interleukin-4 (IL-4) and IL-13. To date, the drug has been approved in more than 60 countries and regions worldwide, with indications covering atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and other diseases.

This approval is based on the positive results of the pivotal Phase II/III clinical study ADEPT. This 52-week randomized, double-blind, placebo-controlled study（n=106）, evaluated Dupilumab(300 mg, once every 2 weeks)Efficacy and Safety of Combination Therapy with OCS vs. Placebo Plus OCS in Adult Patients with Moderate to Severe Bullous Pemphigoid: Primary Endpoint is the Sustained Disease Remission Rate at Week 36.

Specific data show that at 36 weeks of treatment:

• The dupilumab group had18.3% of patients achieved sustained disease remission, compared to 6.1% in the placebo group, reaching the primary endpoint;
  

• DegreeThe Praluent group has38.3% of patients achieved clinically meaningful pruritus reduction, compared to 10.5% in the placebo group;

• DegreePuliyu Monoclonal Antibody GroupThe median cumulative dose of OCS was 2.8 grams, compared to 4.1 grams in the placebo group.

  
  

In terms of safety,Compared with the placebo group,Dupilumab GroupThe Most Common Adverse Events in Patients（≥2%）Including arthralgia, conjunctivitis, blurred vision, herpesvirus infection, and keratitis. Additionally,One case of acute generalized exanthematous pustulosis was reported in the dupilumab group, compared with 0 cases in the placebo group.

Since it was first approved in 2017,Dupilumab, with its continuously expanding indications and significant clinical advantages, has seen a continuous rise in sales.Global sales reached 13.072 billion euros in 2024, increasing by 23.1% year-on-year, firmly maintaining its position as the "top drug" in the field of autoimmune diseases.In Q1 2025, sales reached 3.48 billion euros, a year-on-year increase of 20.3%. The approval of the BP indication will further solidify its market position.

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Editor:Xin Yao

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