Dupixent® (dupilumab) significantly improved sustained disease remission in adults with bullous pemphigoid (BP) compared to placebo, according to an announcement from the manufacturers, Regeneron Pharmaceuticals and Sanofi.
According to a news release, the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Priority Review, with a decision expected by June 20, 2025.
The pivotal clinical trial supporting the sBLA included 106 adults with moderate-to-severe BP, a rare chronic skin condition characterized by blisters, intense itch, and lesions that predominantly affects elderly patients. Results of the study showed patients treated with dupilumab were five times more likely to achieve sustained disease remission (defined as remaining off oral corticosteroids (OCS) and requiring no rescue therapy for at least 20 weeks) vs. placebo. Dupixent was also associated with significant reductions in disease severity, itch, and corticosteroid use.
Adverse events in the dupilumab arm (in at least 3 patients) included peripheral edema, arthralgia, back pain, blurred vision, hypertension, asthma, conjunctivitis, constipation, upper respiratory tract infection, limb injury and insomnia.
In the press release, the manufacturers emphasized that dupilumab in this population provides an option for an unmet need for effective treatments for BP, a condition that affects approximately 27,000 U.S. adults whose disease remains uncontrolled by systemic corticosteroids.
Source: Regeneron press release. February 18, 2025.