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Dupilumab Under FDA Priority Review for Bullous Pemphigoid
Dupilumab has been accepted for priority review by the US Food and Drug Administration (FDA) for the treatment of bullous pemphigoid (BP) in adults, according to a press release from the manufacturer Sanofi.
Dupilumab (Dupixent), a monoclonal antibody that inhibits interleukin (IL)-4 and IL-13 signaling, is currently approved in the United States for a range of dermatologic and allergy indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis.
A decision on dupilumab’s approval for BP is expected by June 20, 2025. If approved, it would be the first and only medication in the United States that specifically targets BP, a condition characterized by blisters, lesions, and skin reddening, as well as intense itchiness, according to the company.
The supplemental Biologics License Application follows dupilumab’s receipt of an orphan drug designation from the FDA, which applies to investigational drugs for rare diseases.
The acceptance of dupilumab for priority review for BP is based in part on data from a pivotal trial known as ADEPT of 106 adults with moderate to severe BP, randomized to 300 mg of subcutaneous dupilumab or a placebo injection every 2 weeks. At 36 weeks, 20% of those treated with dupilumab achieved the primary endpoint of sustained disease remission compared with 4% of those on placebo. Sustained remission was defined as complete clinical remission and completion of an oral corticosteroids taper by 16 weeks without relapse, as well as no use of rescue therapy during the 36-week study treatment period.
The most common adverse events in the dupilumab group (occurring in at least three patients) included peripheral edema, arthralgia, back pain, blurred vision, hypertension, asthma, conjunctivitis, constipation, upper respiratory tract infection, limb injury, and insomnia, according to Sanofi.
The dupilumab studies were funded by Sanofi and Regeneron, the companies co-developing dupilumab.
