Regeneron and Sanofi Report the US FDA’s sBLA Acceptance for Dupixent to Treat Bullous Pemphigoid (BP)
Shots:
- The US FDA has accepted & granted priority review to the sBLA of Dupixent for the treatment of adults with BP (PDUFA: Jun 20, 2025)
- sBLA was supported by P-II/III (ADEPT) trial assessing Dupixent vs PBO in pts (n=106) for 52wks., that met its 1EP of 5x pts achieving sustained disease remission at 36wks. (full clinical remission, OCS-free by 16wks., on Dupixent ≥20wks. with no relapse or rescue therapy use). Reduced disease severity, itch & OCS use was also observed
- Additionally, Dupixent (anti-IL-4/IL-13 mAb) is being investigated in various P-III trials for multiple inflammatory diseases incl. chronic pruritus of unknown origin, BP, & lichen simplex chronicus
Ref: Regeneron | Image: Regeneron & Sanofi
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
