Ruxolitinib Cream Under Review for Atopic Dermatitis
The NDA submission also includes data from the 44-week, open-label, long term extension of both trials.
Atopic Dermatitis
Gusacitinib Fast Tracked for Chronic Hand Eczema
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.
Upadacitinib Bests Dupilumab in Atopic Dermatitis Trial
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.
Abrocitinib Associated With Less Flare in Atopic Dermatitis Trial
The JADE REGIMEN trial was a responder-enriched, placebo-controlled withdrawal study that included a 12-week open-label run-in period.
Abrocitinib Gets Priority Review for Atopic Dermatitis
The New Drug Application includes data from the JADE clinical program.
Topical Live Biotherapeutic Gets Fast Track Status for Atopic Dermatitis
FB-401 is a topically applied live biotherapeutic that consists of 3 therapeutic strains of commensal Roseomonas mucosa.
Delgocitinib Cream Gets Fast Track Status for Chronic Hand Eczema
Delgocitinib is a topical pan-Janus kinase (JAK) inhibitor that blocks the activation of the JAK-STAT pathway.
Second Trial Evaluating Upadacitinib in Atopic Dermatitis Meets End Point
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.
FDA to Review Tralokinumab for Moderate to Severe Atopic Dermatitis
The FDA has accepted for review the Biologics License Application (BLA) for tralokinumab.
Dupixent Prefilled Pen Approval Provides Additional Administration Option
The FDA has approved a prefilled pen formulation of Dupixent (dupilumab; Sanofi and Regeneron), providing another option for administering the treatment.
