ZACKS·2025-06-20 14:51Core Insights - Sanofi and Regeneron received FDA approval for Dupixent to treat bullous pemphigoid, marking it as the first targeted therapy for this condition in the U.S. [1][7] - Dupixent is now approved for eight type II inflammatory diseases in the U.S. [1] Group 1: Dupixent Approval and Indications - Dupixent is approved for treating bullous pemphigoid, a chronic skin disease affecting approximately 27,000 adults in the U.S. [2] - The drug has prior approvals for several conditions, including severe asthma and chronic rhinosinusitis [2][6] - The latest approval is based on phase II/III ADEPT study data showing significant improvements in disease remission and reduced corticosteroid use [6][8] Group 2: Market Performance and Sales - In Q1 2025, Dupixent generated global sales of €3.48 billion, reflecting a 20.3% growth at constant exchange rates [10] - Sanofi anticipates Dupixent will reach around €22 billion in sales by 2030 [10] - Regeneron reported collaboration revenues of $1.18 billion from Sanofi in Q1 2025, a 30% year-over-year increase [10] Group 3: Future Prospects and Regulatory Applications - Regulatory applications for Dupixent in bullous pemphigoid are under review in the EU, Japan, and China [8] - The expanding label of Dupixent reinforces its role in managing type II inflammation-driven diseases, potentially shifting standard-of-care practices [7][8]