US FDA approves Dupixent to treat atopic dermatitis in adults
Sanofi and Regeneron Pharmaceuticals’ Dupixent (dupilumab) injection has been approved by the US Food and Drug Administration (FDA) to treat atopic dermatitis (AD).
AD, a chronic and debilitating form of eczema, is an inflammatory disease with symptoms often appearing as a rash on the skin.
Human monoclonal antibody Dupixent has been designed to specifically inhibit overactive signalling of IL-4 and IL-13 proteins, which are believed to drive the inflammation in AD.
It is available in a pre-filled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose.
Regeneron Pharmaceuticals founding scientist, president, and chief scientific officer George Yancopoulos said: “In atopic dermatitis, Dupixent was shown to help clear the skin and manage the intense itch caused by the disease.
“Today’s approval would not be possible without the dedication of the clinical investigators and the participation of the patients who took part in the global Liberty AD clinical programme.”
The FDA approval was based on data from the global LIBERTY AD clinical programme, which included three randomised Phase III pivotal trials known as SOLO 1, SOLO 2 and CHRONOS.
The studies enrolled 2,119 total adult patients and evaluated Dupixent either alone (SOLO 1 or SOLO 2) or with topical corticosteroids (CHRONOS) in patients with inadequately controlled moderate-to-severe AD.
In 2014, the FDA granted breakthrough therapy designation for Dupixent for inadequately controlled, moderate-to-severe AD.
Sanofi’s specialty care global business unit Sanofi Genzyme and Regeneron will market Dupixent in the US.
Dupixent is a biologic medicine approved to treat adults with moderate-to-severe AD and will be available to US patients later this week.
Dupilumab is currently being evaluated in a development programme for AD, including studies in children with severe AD and adolescents with moderate-to-severe AD.
Image: Atopy of the flexure crease of the elbow. Photo: courtesy of James Heilman, MD.