Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has approved Dupixent (dupilumab) injection, the first biologic agent approved to treat adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent may be used with or without topical corticosteroids.
Dupixent, a human monoclonal antibody, works by inhibiting the overactive signaling of IL-4 and IL-13 proteins, which are believed to play a major role in the persistent inflammation in atopic dermatitis. Dupixent was granted Priority Review by the FDA following its 2014 Breakthrough Therapy designation.
The approval of Dupixent was supported by data from the global LIBERTY AD program, which included three randomized Phase 3 trials (SOLO 1, SOLO 2, and CHRONOS; n=2,119 total). The studies evaluated Dupixent monotherapy or with topical corticosteroids. In SOLO 1 and SOLO 2, the use of Dupixent alone significantly improved measures of skin clearing and overall extent and severity of disease. At 16 weeks, 38% (SOLO 1) and 36% (SOLO 2) of patients receiving Dupixent 300mg every 2 weeks achieved clear or almost clear skin as measured by the 5-point IGA scale (primary endpoint) vs. 10% and 9% with placebo, respectively.
In the CHRONOS study, the use of Dupixent with topical corticosteroids significantly improved measures of overall disease severity at 16 and 52 weeks vs. placebo with topical corticosteroids. At 16 weeks, 39% of patients receiving Dupixent with topical corticosteroids achieved clear or almost clear skin (IGA 0 or 1) vs. 12% of patients receiving placebo with topical corticosteroids.
The most common adverse effects include injection site reactions, cold sores in the mouth or on the lips, and eye and eyelid inflammation. Serious adverse effects include serious allergic reactions, conjunctivitis, and keratitis.
Dupixent will be available as a 300mg/2mL strength single-dose pre-filled syringe in 2-count packs. Dupixent is intended for subcutaneous injection and will launch later this week.
For more information call (844) 387-7936 or visit Regeneron.com.