The phase 3 trial evaluated dupilumab, in addition to standard of care low potency topical corticosteroids, in 162 patients aged 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis.
Factors independently linked to development include atopic dermatitis, family history of psoriasis, skin and fungal infections
Lebrikizumab is a novel humanized monoclonal antibody that selectively inhibits IL-13.
The new 200mg single-dose prefilled pen features a hidden needle and single-press auto-injection, along with visual and audio feedback to help with administration.
Long-term sustained outcomes seen among adults with moderate-to-severe atopic dermatitis
Exposure in utero and during first year of life linked to increased risk for atopic dermatitis; attenuated in sibling-control analysis
The whipped foam formulation allows for rapid absorption to provide fast relief.
The NDA submission also includes data from the 44-week, open-label, long term extension of both trials.
The designation is supported by data from a randomized, double-blind, placebo-controlled phase 2b study that compared gusacitinib to placebo in 97 adult patients with moderate to severe chronic hand eczema.
The randomized, double-blind, double-dummy, active-controlled Heads Up study included 692 patients aged 18 to 75 years with moderate to severe atopic dermatitis who are candidates for systemic therapy.
