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.
The JADE REGIMEN trial was a responder-enriched, placebo-controlled withdrawal study that included a 12-week open-label run-in period.
The New Drug Application includes data from the JADE clinical program.
FB-401 is a topically applied live biotherapeutic that consists of 3 therapeutic strains of commensal Roseomonas mucosa.
Delgocitinib is a topical pan-Janus kinase (JAK) inhibitor that blocks the activation of the JAK-STAT pathway.
Positive results from the second phase 3 study of upadacitinib (Rinvoq; AbbVie) showed that it met all primary and secondary end points for the treatment of moderate to severe atopic dermatitis.
The FDA has accepted for review the Biologics License Application (BLA) for tralokinumab.
The FDA has approved a prefilled pen formulation of Dupixent (dupilumab; Sanofi and Regeneron), providing another option for administering the treatment.
Topline results from a phase 3 study evaluating upadacitinib monotherapy in patients aged ≥12 years with moderate to severe atopic dermatitis (AD) showed the treatment was associated with significant improvement in skin clearance.
Positive topline results were announced from the phase 3 JADE TEEN study evaluating abrocitinib (Pfizer), a Janus Kinase (JAK) inhibitor, in patients aged 12 to <18 years with moderate to severe atopic dermatitis who were also on background topical therapy.
