PARIS (dpa-AFX) - The U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application or sBLA for Dupixent (dupilumab) to treat adults with bullous pemphigoid, Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SNYNF, SNY) said in a statement.
Bullous pemphigoid is a chronic, debilitating and relapsing skin disease with underlying type 2 inflammation characterized by intense itch and blisters, reddening of the skin and painful lesions.
If approved, Dupixent would be the first and only targeted medicine to treat bullous pemphigoid in the U.S.; The FDA decision is expected by June 20, 2025.
The priority review is granted based on positive pivotal results demonstrating significant improvements in sustained disease remission with Dupixent compared to placebo.
Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Dupixent was previously granted Orphan Drug Designation by the FDA for Bullous pemphigoid, which applies to investigational medicines intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S.
Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease in different age population.
Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin, bullous pemphigoid, and lichen simplex chronicus.
REGN closed Friday's regular trading at 673.60 down $0.67 or 0.10%.
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