France major Sanofi (NASDAQ: SNY) and US-based biopharma Regeneron (NASDAQ: REGN) announced that Dupixent (dupilumab) has been approved by the U.S. FDA for a new indication: the treatment of bullous pemphigoid (BP) in adults.
Dupixent’s Mechanism and Previous Approvals
Dupilumab, an IL-4R antagonist co-developed by Sanofi and Regeneron, has previously been approved for multiple type 2 inflammatory diseases, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), prurigo nodularis, and chronic spontaneous urticaria (CSU).
New Indication and Supporting Study
Bullous pemphigoid (BP) is a chronic, debilitating, and frequently relapsing rare skin disorder. The approval for this new indication was supported by the ADEPT study. The study demonstrated that dupilumab significantly improved sustained disease remission, reduced itch symptoms, and decreased the need for oral corticosteroids compared to placebo.-Fineline Info & Tech
