> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Dupixent Approved for Bullous Pemphigoid
- URL: https://www.fdaweb.com/dupixent-approved-for-bullous-pemphigoid/
- Published: 2025-06-20T12:00:00.000Z
- Updated: 2026-09-14T15:14:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159390

FDA has approved Sanofi and Regeneron’s Dupixent (dupilumab) for treating adult patients with bullous pemphigoid (BP), which the companies say is characterized by intense itch, painful blisters, and lesions, as well as reddening of the skin.

Approval is based on data from the pivotal ADEPT Phase 2/3 study that showed 18.3% of Dupixent-treated patients experienced sustained disease remission compared to 6.1% of those taking a placebo, according to the companies. Additionally, 38.3% of Dupixent-treated patients achieved clinically meaningful itch reduction compared to 10.5% of those on placebo.

They say that the most common adverse events more frequently observed in patients on Dupixent compared to placebo were arthralgia, conjunctivitis, blurred vision, herpes viral infections, and keratitis. Additionally, one case of acute generalized exanthematous pustulosis was reported in one patient treated with Dupixent and zero patients treated with placebo.

The companies say the monoclonal antibody Dupixent works by inhibiting the signaling of the IL-4 and IL-13 pathways. It’s currently approved for treating atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis and eosinophilic esophagitis.