The FDA has approved Dupixent (dupilumab) injection, from Sanofi and Regeneron Pharmaceuticals, for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis (AD). Dupixent is indicated for patients whose disease is unable to be controlled by topical prescription therapies, or when those treatments are not advisable. It is the first biologic medicine approved for AD.
Dupixent is a human monoclonal antibody that works by inhibiting overactive signaling of 2 key proteins, IL-4 and IL-13, which are thought to cause the persistent underlying inflammation in AD.
The FDA’s approval is based on data from the global LIBERTY AD clinical program, which included 3, phase 3 trials that examined the use of Dupixent either alone or with topical corticosteroids in patients with inadequately controlled moderate-to-severe AD. Dupixent alone or with topical corticosteroids met its primary and key secondary endpoints in all trials.
Dupixent is available in a pre-filled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose. Dupixent can be used with or without topical corticosteroids, but should not be used in patients who are allergic to dupilumab or any of the drug’s ingredients.
AD, which is the most common form of eczema, is characterized by rashes on the skin that can include symptoms such as intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing.
The most common adverse events with the injection include injection site reactions, eye and eye lid inflammation including redness, swelling, and itching, and cold sores in the mouth or on the lips.
Sanofi and Regeneron announce FDA approval of Dupixent (dupilumab), the first targeted biologic therapy for adults with moderate-to-severe atopic dermatitis [news release]. New Jersey. Sanofi’s website. Accessed Mar. 28, 2017.